Staphylococcal Infection
Conditions
Keywords
Methicillin, Staphylococcus aureus, MRSA
Brief summary
The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks.
Detailed description
Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has recently emerged as a cause of skin and soft-tissue infection (SSTI). In the current era of increasing CA-MRSA infections, the outpatient management of SSTIs has not been well studied. This will be a clinical trial to evaluate oral off-patent antibiotics for outpatient treatment of patients with any of the 3 main types of acute uncomplicated SSTI, i.e., abscesses, infected wounds, and cellulitis. Upon enrollment, subjects will be stratified by type of infection, and then randomized to various treatments. Subjects with an acute uncomplicated cutaneous abscess receiving incision and drainage (I&D) will be treated with Trimethoprim/Sulfamethoxazole (TMP/SMX) or placebo to determine whether the addition of an antibiotic with activity against CA-MRSA is more clinically efficacious than I&D alone. Subjects with an acute wound infection will be treated with TMP/SMX or clindamycin to determine if clindamycin, an antibiotic with activity against CA-MRSA, methicillin-susceptible Staphylococcus aureus (MSSA), and streptococci is more clinically efficacious than TMP/SMX, an antibiotic with activity against CA-MRSA and MSSA. Subjects with acute cellulitis will be treated with cephalexin/TMP/SMX or cephalexin/placebo to determine if cephalexin/TMP/SMX is more clinically efficacious than cephalexin alone. The primary objectives for each type of SSTI studied are to compare the cure rates in the per protocol (PP) population. Secondary objectives provide additional means of assessment for the clinical efficacy of the employed interventions and resolution of the infection and include describing microbiological cure, change in the dimension of erythema, composite cure, surgical procedures, invasive and recurrent infections, infections in household contacts, and time to normal activity and until analgesics are no longer used at various times in the PP/ modified intent-to-treat (mITT) populations. This is a multi-center, randomized, double-blind clinical trial in which subjects will be stratified by the type of infection and then randomized to various 7-day oral antibiotic treatments, including placebo-controlled and comparative designs. The study population will include children 13 years of age and over and adults, who weigh greater than or equal to 40 kg presenting to 5 large urban emergency departments. Therapy will start on the day of enrollment. Subjects will be evaluated upon enrollment, at 2-3 days after enrollment (OTV), at 1-3 days after the end-of-therapy (EOT), at 7-14 days after the end-of-therapy (TOC), and at 6-8 weeks after the end-of-therapy (EFV).
Interventions
OTHERPlacebo
Placebo tablet administered orally.
DRUGCephalexin
500 mg, four times per day.
DRUGClindamycin
300 mg, four times per day.
DRUGTrimethoprim-sulfamethoxazole
4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg); * Have a skin and soft tissue infection (SSTI) with all three local findings of erythema (\> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of: 1. Abscess - a fluctuant and/or indurated lesion, or findings of a fluid-filled cavity on soft tissue ultrasound evaluation that, when opened reveals purulent material, receiving incision and drainage (I&D) (considered standard care for abscess) and having a minimum diameter (along any axis) of at least 2 cm (measured from the borders of induration, if a fluctuant lesion, or borders of the abscess cavity on ultrasound, if not fluctuant). Note: Although I&D of an abscess is considered standard care (i.e., patients will receive I&D whether or not they are enrolled in the study), the procedure may be performed after enrollment into the study so that prior measurements of the area of erythema and swelling/induration can be obtained unless it is an occult abscess in which the I&D will be performed prior to enrollment to verify infection type and ensure correct classification of the subject. 2. Infected Wound - a wound (defined as any apparent break in the skin) with any apparent drainage limited in depth to only involving skin and subcutaneous tissue, including sutured cutaneous wounds not involving intra-abdominal surgeries contaminated with bacterial or bowel contents (e.g., colon surgery and empyema drainage), and 3. Cellulitis - an area of erythema without the presence of a wound with drainage or abscess; Cellulitis associated with an abscess will be categorized as an abscess. Cellulitis associated with an infected wound will be classified as an infected wound. Patients with cellulitis and an abscess less than 2 cm will be excluded. Infected wound associated with an abscess that may require I&D, will be classified as an infected wound. * Have the infected lesion for 7 days or less duration; * Are to receive outpatient treatment at enrollment/baseline; * Express willingness and ability to be contacted and return for re-evaluation according to the study protocol; * Provide written informed consent (and for subjects ages 13-17, consent from their guardian and assent); * Negative pregnancy test for subjects who are women of childbearing potential.
Exclusion criteria
* Severe allergy or reaction to study drug or drugs similar to the study drug relevant to whichever study sub-trial the subject would be assigned to (e.g., patients with severe or life-threatening penicillin allergies, allergy to any cephalosporin, clindamycin, or sulfonamides, or any other drug containing sulfur such as thiazides, furosemide, and oral sulfonylureas); * Concomitant treatment (i.e., while on study drug therapy) with coumadin, phenytoin, or methotrexate, or suspected G-6-PD or folic acid deficiency; * Expected inability to swallow or absorb the study drug (assessed by patient history); * Pregnancy, nursing, or expectation of becoming pregnant while on study drug; * Perirectal (within 5 cm of anus), perineal non-skin lesions (i.e., mucosal), or paronychial location of infection. Scrotal and labial abscesses will not be excluded. * An infection due to a mammalian bite; * Treatment with a study drug relevant to their infection type, or another systemic antibiotic in the previous 48 hours (i.e., before screening/baseline) unless associated with treatment failure which is defined as a patient who has been on prior (non study drug) antibiotics for at least 72 hours and failed. * Expected concurrent treatment with a topical antibiotic or another systemic antibiotic up to Test-of-Cure Visit (TOC) (note: if patient was using a topical antibiotic previously, they can still be enrolled if they agree to stop using it); * Immunodeficiency \[e.g., absolute neutrophil count \<500/mm\^3, chronic immunosuppressive drugs, active chemotherapy, or known acquired immunodeficiency syndrome (AIDS) (CD4 count \<200 or AIDS-defining illness within the last year) assessed by patient history\]. Note: patients who had prior AIDS-defining illness or CD4 count \<200 in the past may be enrolled if most recent CD4 count \>200; * Burn or active chronic skin condition (e.g., including rash or eczema) related to the skin and soft-tissue infection (SSTI) at screening/baseline; * Infection related to currently indwelling device (e.g., intravenous line), excepting sutures associated with qualifying infected wounds which will be removed upon enrollment; * Infection for which prior cultures reveal in vitro resistance of a pathogen to a study drug in the previous month prior to screening/baseline; * Known or suspected osteomyelitis or septic arthritis; * Infection related to diabetic foot, decubitus, or ischemic ulcer; * Known severe renal insufficiency (creatinine clearance \< 50 mL/min) calculated by measurement of serum creatinine if patient provides this history or based on past studies at baseline/enrollment; * Prior enrollment in this study within 12 weeks; * Another active infection of another organ system (e.g., pneumonia) or more than one active (i.e., currently on antibiotic treatment and/or requiring I&D) SSTI site (e.g., a site noncontiguous with the infection under study). Note: Minor folliculitis at secondary site is not an exclusion; * Presence of an abscess that has completely drained, either spontaneously or by a healthcare provider prior to enrollment; * An infected wound or cellulitis that has been surgically explored (\>1 cm incision) and does not reveal an abscess. Cellulitis that has been needled, minimally incised (less than or equal to 1 cm) or punch biopsied and no purulent drainage found can still be enrolled; * Currently incarcerated in a detention facility or in police custody (note: patients wearing a monitoring device can be enrolled) at baseline/screening; * For patients with an infected wound, history of C. difficile infection, pseudomembranous colitis, or active diarrhea at baseline/screening; * For patients with an infected wound, severe liver disease based on patient history; * An intravenous (IV) drug user in the last month with current presence of fever; * Current residence in a nursing home or other long term care facility at baseline/screening; * Expected use of other investigational drug or vaccine while on study drug; * For patients with an abscess, cardiac conditions associated with the highest risk of adverse outcome from endocarditis for which prophylaxis is reasonable, including patients with prosthetic cardiac valve or prosthetic material used for cardiac valve repair, history of previous infective endocarditis, congenital heart disease (excluding mitral valve prolapse), and history of cardiac transplantation recipients who develop cardiac valvulopathy; * Presence of an organic foreign body, e.g., wood (note: subjects with embedded non-organic materials, e.g., metal or glass, that can be completely removed can still be enrolled if physician is certain there is no foreign body left).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Days 14-21 | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | Day 1 to Day 3-4 | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | Day 1 to Day 3-4 | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | Day 1 to Day 8-10 | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | Day 1 to Day 8-10 | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | Day 1 to Day 14-21 | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | Day 1 to Day 14-21 | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. |
| Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Day 14-21 | Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary. |
| Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Day 14-21 | Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria. |
| Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | Day 1 through Day 14-21 | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. |
| Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | Day 1 through Day 14-21 | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. |
| Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | Day 1 through Day 49-63 | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. |
| Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | Day 1 through Day 49-63 | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. |
| Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | Day 1 through Day 14-21 | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. |
| Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | Day 1 through Day 14-21 | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. |
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Days 14-21 | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. |
| Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | Day 1 through Day 49-63 | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | Day 1 through Day 14-21 | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | Day 1 through Day 14-21 | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | Day 1 through Day 49-63 | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | Day 1 through Day 49-63 | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. |
| Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | Day 1 through Day 14-21 | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. |
| Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | Day 1 through Day 14-21 | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. |
| Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | Day 1 through Day 49-63 | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. |
| Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | Day 1 through Day 49-63 | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. |
| Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Day 1 through Day 49-63 | All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class. |
| Mean Days Missed From Normal Activities in the Per Protocol Population | Day 1 through 14 | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. |
| Mean Days Missed From Normal Activities in the Intent to Treat Population | Day 1 through 14 | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. |
| Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 through 14 | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. |
| Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 through 14 | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. |
| Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | Day 1 through Day 49-63 | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between 13APR2009 and 16APR2013 from those who presented with an abscess, infected wound, or cellulitis at emergency departments at each of the clinical sites.
Participants by arm
| Arm | Count |
|---|---|
| Abscess, Placebo Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day. | 533 |
| Abscess, TMP/SMX Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. | 524 |
| Infected Wound, TMP/SMX Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. | 198 |
| Infected Wound, Clindamycin Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. | 203 |
| Cellulitis, Cephalexin and TMP/SMX Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. | 218 |
| Cellulitis, Cephalexin Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. | 193 |
| Total | 1,869 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Did not meet eligibility criteria | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Incarcerated | 0 | 2 | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 49 | 58 | 18 | 33 | 18 | 23 |
| Overall Study | Physician Decision | 7 | 16 | 2 | 0 | 5 | 8 |
| Overall Study | Randomized but not treated | 12 | 6 | 1 | 0 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 5 | 6 | 0 | 4 | 2 |
Baseline characteristics
| Characteristic | Total | Abscess, Placebo | Abscess, TMP/SMX | Infected Wound, TMP/SMX | Infected Wound, Clindamycin | Cellulitis, Cephalexin and TMP/SMX | Cellulitis, Cephalexin |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 17 Participants | 10 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants |
| Age, Categorical >=65 years | 26 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 9 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1803 Participants | 513 Participants | 511 Participants | 191 Participants | 195 Participants | 206 Participants | 187 Participants |
| Age, Continuous | 38.0 years STANDARD_DEVIATION 12.9 | 36.8 years STANDARD_DEVIATION 12.3 | 37.0 years STANDARD_DEVIATION 12.6 | 40.4 years STANDARD_DEVIATION 13.1 | 38.0 years STANDARD_DEVIATION 13.3 | 39.7 years STANDARD_DEVIATION 13.3 | 39.4 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 628 Participants | 180 Participants | 178 Participants | 63 Participants | 72 Participants | 75 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1240 Participants | 353 Participants | 346 Participants | 134 Participants | 131 Participants | 143 Participants | 133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 752 Participants | 233 Participants | 232 Participants | 71 Participants | 73 Participants | 75 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 69 Participants | 22 Participants | 22 Participants | 7 Participants | 3 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 65 Participants | 21 Participants | 18 Participants | 5 Participants | 8 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 962 Participants | 252 Participants | 244 Participants | 115 Participants | 117 Participants | 123 Participants | 111 Participants |
| Region of Enrollment United States | 1869 participants | 533 participants | 524 participants | 198 participants | 203 participants | 218 participants | 193 participants |
| Sex: Female, Male Female | 763 Participants | 225 Participants | 221 Participants | 65 Participants | 81 Participants | 81 Participants | 90 Participants |
| Sex: Female, Male Male | 1106 Participants | 308 Participants | 303 Participants | 133 Participants | 122 Participants | 137 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 331 / 617 | 345 / 630 | 138 / 250 | 127 / 249 | 157 / 248 | 149 / 248 |
| serious Total, serious adverse events | 30 / 617 | 21 / 630 | 15 / 250 | 11 / 249 | 20 / 248 | 21 / 248 |
Outcome results
Primary
Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Time frame: Days 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 457 participants |
| Abscess, Placebo | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 76 participants |
| Abscess, TMP/SMX | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 487 participants |
| Abscess, TMP/SMX | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 37 participants |
| Infected Wound, TMP/SMX | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 182 participants |
| Infected Wound, TMP/SMX | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 16 participants |
| Infected Wound, Clindamycin | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 187 participants |
| Infected Wound, Clindamycin | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 16 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 182 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 36 participants |
| Cellulitis, Cephalexin | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 165 participants |
| Cellulitis, Cephalexin | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 28 participants |
Secondary
Mean Days Missed From Normal Activities in the Intent to Treat Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Time frame: Day 1 through 14
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abscess, Placebo | Mean Days Missed From Normal Activities in the Intent to Treat Population | 2.5 days | Standard Deviation 3.7 |
| Abscess, TMP/SMX | Mean Days Missed From Normal Activities in the Intent to Treat Population | 2.1 days | Standard Deviation 3.2 |
| Infected Wound, TMP/SMX | Mean Days Missed From Normal Activities in the Intent to Treat Population | 2.6 days | Standard Deviation 4 |
| Infected Wound, Clindamycin | Mean Days Missed From Normal Activities in the Intent to Treat Population | 2.1 days | Standard Deviation 3.4 |
| Cellulitis, Cephalexin and TMP/SMX | Mean Days Missed From Normal Activities in the Intent to Treat Population | 2.2 days | Standard Deviation 3.2 |
| Cellulitis, Cephalexin | Mean Days Missed From Normal Activities in the Intent to Treat Population | 2.7 days | Standard Deviation 4.1 |
Secondary
Mean Days Missed From Normal Activities in the Per Protocol Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Time frame: Day 1 through 14
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abscess, Placebo | Mean Days Missed From Normal Activities in the Per Protocol Population | 2.6 days | Standard Deviation 3.8 |
| Abscess, TMP/SMX | Mean Days Missed From Normal Activities in the Per Protocol Population | 2.0 days | Standard Deviation 3.1 |
| Infected Wound, TMP/SMX | Mean Days Missed From Normal Activities in the Per Protocol Population | 2.7 days | Standard Deviation 4.1 |
| Infected Wound, Clindamycin | Mean Days Missed From Normal Activities in the Per Protocol Population | 2.1 days | Standard Deviation 3.5 |
| Cellulitis, Cephalexin and TMP/SMX | Mean Days Missed From Normal Activities in the Per Protocol Population | 2.2 days | Standard Deviation 3.2 |
| Cellulitis, Cephalexin | Mean Days Missed From Normal Activities in the Per Protocol Population | 2.5 days | Standard Deviation 3.9 |
Secondary
Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.
Time frame: Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Cure | 396 participants |
| Abscess, Placebo | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Failure | 137 participants |
| Abscess, TMP/SMX | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Cure | 453 participants |
| Abscess, TMP/SMX | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Failure | 71 participants |
| Infected Wound, TMP/SMX | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Cure | 113 participants |
| Infected Wound, TMP/SMX | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Failure | 85 participants |
| Infected Wound, Clindamycin | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Failure | 89 participants |
| Infected Wound, Clindamycin | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Cure | 114 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Cure | 160 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Failure | 58 participants |
| Cellulitis, Cephalexin | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Failure | 44 participants |
| Cellulitis, Cephalexin | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Composite Clinical Cure | 149 participants |
Secondary
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Time frame: Day 1 through 14
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 6 | 34 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 7 | 27 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 3 | 45 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 4 | 47 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 12 | 19 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 9 | 24 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 10 | 14 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 5 | 27 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 11 | 19 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 13 | 15 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 8 | 34 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 | 58 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 14 | 146 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 2 | 38 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 6 | 29 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 2 | 34 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 10 | 15 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 | 81 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 4 | 34 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 14 | 127 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 3 | 64 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 5 | 42 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 13 | 5 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 8 | 40 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 12 | 14 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 7 | 32 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 9 | 26 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 11 | 10 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 4 | 16 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 5 | 9 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 7 | 13 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 10 | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 11 | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 | 32 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 2 | 15 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 3 | 18 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 6 | 13 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 8 | 8 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 9 | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 12 | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 13 | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 14 | 59 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 2 | 10 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 6 | 13 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 | 37 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 8 | 11 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 5 | 9 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 9 | 9 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 10 | 4 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 11 | 4 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 12 | 3 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 7 | 12 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 14 | 50 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 13 | 7 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 3 | 24 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 4 | 10 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 8 | 10 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 11 | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 3 | 15 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 9 | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 10 | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 13 | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 7 | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 14 | 51 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 4 | 16 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 | 18 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 2 | 7 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 6 | 10 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 12 | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 5 | 10 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 12 | 6 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 8 | 6 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 14 | 45 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 4 | 13 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 3 | 10 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 5 | 4 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 2 | 6 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 1 | 28 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 10 | 4 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 6 | 22 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 9 | 6 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 11 | 2 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 7 | 8 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | Day 13 | 3 participants |
Secondary
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Time frame: Day 1 through 14
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 10 | 12 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 13 | 12 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 5 | 24 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 7 | 24 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 14 | 130 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 4 | 39 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 9 | 22 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 | 44 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 2 | 37 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 12 | 18 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 8 | 31 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 11 | 16 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 6 | 29 participants |
| Abscess, Placebo | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 3 | 41 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 | 56 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 8 | 35 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 2 | 32 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 9 | 21 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 10 | 13 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 3 | 49 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 14 | 107 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 4 | 32 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 13 | 3 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 5 | 40 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 6 | 27 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 11 | 10 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 12 | 12 participants |
| Abscess, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 7 | 27 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 11 | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 3 | 17 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 12 | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 14 | 46 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 10 | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 6 | 10 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 7 | 10 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 8 | 7 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 4 | 14 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 13 | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 2 | 11 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 | 23 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 9 | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 5 | 7 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 11 | 4 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 | 29 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 2 | 9 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 3 | 18 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 4 | 9 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 5 | 9 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 6 | 11 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 7 | 12 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 8 | 10 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 9 | 7 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 12 | 1 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 13 | 6 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 14 | 40 participants |
| Infected Wound, Clindamycin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 10 | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 12 | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 6 | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 3 | 13 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 5 | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 | 14 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 14 | 45 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 7 | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 11 | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 10 | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 4 | 15 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 2 | 7 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 9 | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 13 | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 8 | 9 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 13 | 2 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 11 | 1 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 6 | 19 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 5 | 4 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 12 | 6 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 4 | 7 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 1 | 17 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 7 | 6 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 3 | 7 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 2 | 5 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 14 | 38 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 8 | 5 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 10 | 3 participants |
| Cellulitis, Cephalexin | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | Day 9 | 4 participants |
Secondary
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.
Time frame: Day 1 through Day 49-63
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | 76 participants |
| Abscess, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | 52 participants |
| Infected Wound, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | 20 participants |
| Infected Wound, Clindamycin | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | 12 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | 33 participants |
| Cellulitis, Cephalexin | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | 31 participants |
Secondary
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.
Time frame: Day 1 through Day 49-63
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | 69 participants |
| Abscess, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | 42 participants |
| Infected Wound, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | 17 participants |
| Infected Wound, Clindamycin | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | 8 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | 33 participants |
| Cellulitis, Cephalexin | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | 20 participants |
Secondary
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.
Time frame: Day 1 through Day 14-21
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | 52 participants |
| Abscess, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | 25 participants |
| Infected Wound, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | 16 participants |
| Infected Wound, Clindamycin | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | 26 participants |
| Cellulitis, Cephalexin | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | 28 participants |
Secondary
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.
Time frame: Day 1 through Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | 46 participants |
| Abscess, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | 18 participants |
| Infected Wound, TMP/SMX | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | 13 participants |
| Infected Wound, Clindamycin | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | 26 participants |
| Cellulitis, Cephalexin | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | 17 participants |
Secondary
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Time frame: Day 1 through Day 49-63
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | 26 participants |
| Abscess, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | 30 participants |
| Infected Wound, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | 16 participants |
| Infected Wound, Clindamycin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | 35 participants |
| Cellulitis, Cephalexin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | 31 participants |
Secondary
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Time frame: Day 1 through Day 49-63
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | 23 participants |
| Abscess, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | 26 participants |
| Infected Wound, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | 14 participants |
| Infected Wound, Clindamycin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | 33 participants |
| Cellulitis, Cephalexin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | 24 participants |
Secondary
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Time frame: Day 1 through Day 14-21
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | 17 participants |
| Abscess, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | 13 participants |
| Infected Wound, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | 15 participants |
| Infected Wound, Clindamycin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | 32 participants |
| Cellulitis, Cephalexin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | 29 participants |
Secondary
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Time frame: Day 1 through Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | 16 participants |
| Abscess, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | 11 participants |
| Infected Wound, TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | 13 participants |
| Infected Wound, Clindamycin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | 30 participants |
| Cellulitis, Cephalexin | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | 22 participants |
Secondary
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.
Time frame: Day 1 through Day 49-63
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Skin and subcutaneous tissue disorders | 10 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Cardiac disorders | 0 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Vascular disorders | 2 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Nervous system disorders | 38 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Metabolism and nutrition disorders | 7 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Psychiatric disorders | 0 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Investigations | 1 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Renal and urinary disorders | 2 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Injury, poisoning and procedural complications | 1 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Reproductive system and breast disorders | 1 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Infections and infestations | 5 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | General disorders and administration site conditio | 6 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Respiratory, thoracic and mediastinal disorders | 3 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Musculoskeletal and connective tissue disorders | 3 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Gastrointestinal disorders | 164 participants |
| Abscess, Placebo | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Eye disorders | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Eye disorders | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Metabolism and nutrition disorders | 11 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Cardiac disorders | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Gastrointestinal disorders | 198 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Renal and urinary disorders | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Infections and infestations | 4 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Vascular disorders | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Skin and subcutaneous tissue disorders | 14 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Nervous system disorders | 44 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Psychiatric disorders | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Reproductive system and breast disorders | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Investigations | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | General disorders and administration site conditio | 11 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Musculoskeletal and connective tissue disorders | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Respiratory, thoracic and mediastinal disorders | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Injury, poisoning and procedural complications | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Investigations | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Musculoskeletal and connective tissue disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Nervous system disorders | 16 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Psychiatric disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Reproductive system and breast disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Respiratory, thoracic and mediastinal disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Skin and subcutaneous tissue disorders | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Vascular disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Renal and urinary disorders | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | General disorders and administration site conditio | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Cardiac disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Gastrointestinal disorders | 82 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Infections and infestations | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Injury, poisoning and procedural complications | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Eye disorders | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Metabolism and nutrition disorders | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Injury, poisoning and procedural complications | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Nervous system disorders | 15 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | General disorders and administration site conditio | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Cardiac disorders | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Renal and urinary disorders | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Reproductive system and breast disorders | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Infections and infestations | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Metabolism and nutrition disorders | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Eye disorders | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Skin and subcutaneous tissue disorders | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Investigations | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Respiratory, thoracic and mediastinal disorders | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Psychiatric disorders | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Musculoskeletal and connective tissue disorders | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Gastrointestinal disorders | 93 participants |
| Infected Wound, Clindamycin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Vascular disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Skin and subcutaneous tissue disorders | 15 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Metabolism and nutrition disorders | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Cardiac disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Respiratory, thoracic and mediastinal disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Eye disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Gastrointestinal disorders | 87 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Reproductive system and breast disorders | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | General disorders and administration site conditio | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Infections and infestations | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Psychiatric disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Musculoskeletal and connective tissue disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Injury, poisoning and procedural complications | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Nervous system disorders | 16 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Investigations | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Vascular disorders | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Renal and urinary disorders | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Injury, poisoning and procedural complications | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Reproductive system and breast disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Nervous system disorders | 20 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Skin and subcutaneous tissue disorders | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Eye disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Musculoskeletal and connective tissue disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Investigations | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Respiratory, thoracic and mediastinal disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Renal and urinary disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Cardiac disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Infections and infestations | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | General disorders and administration site conditio | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Metabolism and nutrition disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Vascular disorders | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Gastrointestinal disorders | 73 participants |
| Cellulitis, Cephalexin | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | Psychiatric disorders | 0 participants |
Secondary
Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Time frame: Days 14-21
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Cure | 454 participants |
| Abscess, Placebo | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Failure | 163 participants |
| Abscess, TMP/SMX | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Cure | 507 participants |
| Abscess, TMP/SMX | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Failure | 123 participants |
| Infected Wound, TMP/SMX | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Cure | 197 participants |
| Infected Wound, TMP/SMX | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Failure | 53 participants |
| Infected Wound, Clindamycin | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Cure | 198 participants |
| Infected Wound, Clindamycin | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Failure | 51 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Cure | 189 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Failure | 59 participants |
| Cellulitis, Cephalexin | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Cure | 171 participants |
| Cellulitis, Cephalexin | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical Failure | 77 participants |
Secondary
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time frame: Day 1 through Day 49-63
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | 0 participants |
Secondary
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time frame: Day 1 through Day 49-63
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | 0 participants |
Secondary
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time frame: Day 1 through Day 14-21
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | 0 participants |
Secondary
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time frame: Day 1 through Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | 0 participants |
Secondary
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.
Time frame: Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Presumed eradication | 457 participants |
| Abscess, Placebo | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Persistence | 39 participants |
| Abscess, Placebo | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | New infection | 1 participants |
| Abscess, Placebo | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Super-infection | 8 participants |
| Abscess, Placebo | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Unclassified | 28 participants |
| Abscess, Placebo | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Indeterminate | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Persistence | 15 participants |
| Abscess, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Super-infection | 4 participants |
| Abscess, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Indeterminate | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Presumed eradication | 487 participants |
| Abscess, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | New infection | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Unclassified | 18 participants |
| Infected Wound, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Indeterminate | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Unclassified | 9 participants |
| Infected Wound, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Super-infection | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | New infection | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Presumed eradication | 182 participants |
| Infected Wound, TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Persistence | 5 participants |
| Infected Wound, Clindamycin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Super-infection | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Persistence | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | New infection | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Indeterminate | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Unclassified | 9 participants |
| Infected Wound, Clindamycin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Presumed eradication | 187 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Presumed eradication | 182 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Unclassified | 13 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Persistence | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | New infection | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Super-infection | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Indeterminate | 23 participants |
| Cellulitis, Cephalexin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Super-infection | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | New infection | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Unclassified | 11 participants |
| Cellulitis, Cephalexin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Indeterminate | 17 participants |
| Cellulitis, Cephalexin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Persistence | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Presumed eradication | 165 participants |
Secondary
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Time frame: Day 1 through Day 49-63
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | 35 participants |
| Abscess, TMP/SMX | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | 25 participants |
| Infected Wound, TMP/SMX | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | 11 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | 11 participants |
| Cellulitis, Cephalexin | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | 5 participants |
Secondary
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Time frame: Day 1 through Day 49-63
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | 33 participants |
| Abscess, TMP/SMX | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | 20 participants |
| Infected Wound, TMP/SMX | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | 10 participants |
| Cellulitis, Cephalexin | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | 5 participants |
Secondary
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Time frame: Day 1 through Day 14-21
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | 22 participants |
| Abscess, TMP/SMX | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | 12 participants |
| Infected Wound, TMP/SMX | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | 4 participants |
Secondary
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Time frame: Day 1 through Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abscess, Placebo | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | 22 participants |
| Abscess, TMP/SMX | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | 9 participants |
| Infected Wound, TMP/SMX | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | 4 participants |
Secondary
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time frame: Day 1 to Day 8-10
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | No reduction | 5 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 1 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 3 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 6 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 7 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 9 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 531 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 7 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | No reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 5 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 9 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 532 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 5 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 197 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | No reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | No reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 208 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | No reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 198 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 4 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | No reduction | 5 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 188 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 3 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
Secondary
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time frame: Day 1 to Day 8-10
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | No reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >5%-10% reduction | 1 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >25%-30% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >35%-40% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >45%-50% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >50%-55% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >60%-65% reduction | 1 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >65%-70% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >70%-75% reduction | 3 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >75%-80% reduction | 6 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >80%-85% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >85%-90% reduction | 7 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >90%-95% reduction | 9 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >95%-100% reduction | 478 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >30%-35% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >10%-15% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >90%-95% reduction | 7 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >40%-45% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >35%-40% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | No reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >80%-85% reduction | 5 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >85%-90% reduction | 7 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >75%-80% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >95%-100% reduction | 478 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >70%-75% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >65%-70% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >25%-30% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >55%-60% reduction | 5 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >50%-55% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >10%-15% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >85%-90% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >25%-30% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >40%-45% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >45%-50% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >90%-95% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >50%-55% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >55%-60% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >60%-65% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >65%-70% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >70%-75% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >75%-80% reduction | 2 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >95%-100% reduction | 167 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >80%-85% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | No reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >80%-85% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >85%-90% reduction | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >75%-80% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >65%-70% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >70%-75% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >90%-95% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >55%-60% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >45%-50% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >50%-55% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | No reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >60%-65% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >95%-100% reduction | 182 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >50%-55% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >55%-60% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >90%-95% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >60%-65% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >65%-70% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >70%-75% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >20%-25% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >75%-80% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >5%-10% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | No reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >80%-85% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >35%-40% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >95%-100% reduction | 183 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >30%-35% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >85%-90% reduction | 4 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >90%-95% reduction | 4 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >25%-30% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >60%-65% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >80%-85% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | No reduction | 5 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >85%-90% reduction | 4 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >30%-35% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >50%-55% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >55%-60% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >70%-75% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >95%-100% reduction | 162 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >65%-70% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >75%-80% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >40%-45% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
Secondary
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time frame: Day 1 to Day 3-4
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | No reduction | 67 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 14 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 3 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 15 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 12 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 298 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 20 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 7 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 21 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 17 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 3 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 20 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 15 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 13 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 12 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 20 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 13 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 18 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 12 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 8 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 15 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 11 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 7 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 16 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 4 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 16 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 20 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 7 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 328 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 22 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 5 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 20 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 6 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | No reduction | 43 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 10 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 15 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 24 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 17 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 12 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 9 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 7 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 7 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 8 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 7 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 11 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 111 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 10 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | No reduction | 12 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 5 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 4 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 7 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 8 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 7 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 9 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 17 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | No reduction | 18 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 11 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 11 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 108 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 16 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | No reduction | 34 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 7 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 11 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 74 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 11 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 9 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >95%-100% reduction | 80 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >75%-80% reduction | 8 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >85%-90% reduction | 9 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >55%-60% reduction | 8 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >60%-65% reduction | 4 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >30%-35% reduction | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >5%-10% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >25%-30% reduction | 3 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >50%-55% reduction | 9 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >45%-50% reduction | 10 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >65%-70% reduction | 9 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >35%-40% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >20%-25% reduction | 5 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >80%-85% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >90%-95% reduction | 8 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >0%-5% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >70%-75% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >15%-20% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >40%-45% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | No reduction | 41 participants |
Secondary
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time frame: Day 1 to Day 3-4
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | No reduction | 59 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >0%-5% reduction | 3 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >5%-10% reduction | 1 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >10%-15% reduction | 3 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >15%-20% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >20%-25% reduction | 6 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >25%-30% reduction | 11 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >30%-35% reduction | 13 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >35%-40% reduction | 12 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >40%-45% reduction | 16 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >45%-50% reduction | 12 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >50%-55% reduction | 13 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >55%-60% reduction | 10 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >60%-65% reduction | 14 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >65%-70% reduction | 19 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >70%-75% reduction | 14 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >75%-80% reduction | 13 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >80%-85% reduction | 19 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >85%-90% reduction | 18 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >90%-95% reduction | 13 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >95%-100% reduction | 262 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >45%-50% reduction | 12 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >30%-35% reduction | 7 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >10%-15% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >90%-95% reduction | 16 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >40%-45% reduction | 15 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >35%-40% reduction | 13 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | No reduction | 37 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >80%-85% reduction | 18 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >75%-80% reduction | 21 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >85%-90% reduction | 13 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >20%-25% reduction | 3 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >5%-10% reduction | 4 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >95%-100% reduction | 284 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >70%-75% reduction | 17 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >65%-70% reduction | 9 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >0%-5% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >25%-30% reduction | 6 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >15%-20% reduction | 6 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >60%-65% reduction | 21 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >55%-60% reduction | 10 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >50%-55% reduction | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >10%-15% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >15%-20% reduction | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >20%-25% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >85%-90% reduction | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >25%-30% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >30%-35% reduction | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >35%-40% reduction | 3 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >40%-45% reduction | 7 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >45%-50% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >90%-95% reduction | 5 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >50%-55% reduction | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >55%-60% reduction | 4 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >60%-65% reduction | 12 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >65%-70% reduction | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >70%-75% reduction | 8 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >75%-80% reduction | 6 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >95%-100% reduction | 87 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >80%-85% reduction | 8 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | No reduction | 11 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >0%-5% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >5%-10% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >80%-85% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | No reduction | 17 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >15%-20% reduction | 5 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >65%-70% reduction | 5 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >90%-95% reduction | 10 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >75%-80% reduction | 16 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >85%-90% reduction | 8 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >10%-15% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >70%-75% reduction | 7 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >40%-45% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >20%-25% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >55%-60% reduction | 2 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >45%-50% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >95%-100% reduction | 89 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >50%-55% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >25%-30% reduction | 3 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >0%-5% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >60%-65% reduction | 6 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >30%-35% reduction | 5 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >35%-40% reduction | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >10%-15% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >45%-50% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >0%-5% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >50%-55% reduction | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >25%-30% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >55%-60% reduction | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >90%-95% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >80%-85% reduction | 10 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >60%-65% reduction | 15 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >65%-70% reduction | 7 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >20%-25% reduction | 4 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >70%-75% reduction | 9 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >85%-90% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >75%-80% reduction | 8 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >5%-10% reduction | 5 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >15%-20% reduction | 3 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | No reduction | 30 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >35%-40% reduction | 6 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >95%-100% reduction | 71 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >30%-35% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >40%-45% reduction | 8 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >5%-10% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >80%-85% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >20%-25% reduction | 4 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >45%-50% reduction | 9 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | No reduction | 33 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >85%-90% reduction | 8 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >30%-35% reduction | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >90%-95% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >60%-65% reduction | 3 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >40%-45% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >35%-40% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >70%-75% reduction | 5 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >15%-20% reduction | 2 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >95%-100% reduction | 67 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >65%-70% reduction | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >50%-55% reduction | 6 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >25%-30% reduction | 3 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >75%-80% reduction | 7 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >55%-60% reduction | 8 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | >0%-5% reduction | 2 participants |
Secondary
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time frame: Day 1 to Day 14-21
Population: All subjects who took at least one dose of study medication were included in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >75%-80% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >50%-55% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >65%-70% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >95%-100% reduction | 561 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >90%-95% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >70%-75% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >25%-30% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >80%-85% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | No reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >85%-90% reduction | 4 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >50%-55% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >25%-30% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | No reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >80%-85% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >75%-80% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >85%-90% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >70%-75% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >90%-95% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >65%-70% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >95%-100% reduction | 559 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >20%-25% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | No reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >25%-30% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >75%-80% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >65%-70% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >10%-15% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >50%-55% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >90%-95% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >70%-75% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >95%-100% reduction | 216 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >80%-85% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >85%-90% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >65%-70% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | No reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >85%-90% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >90%-95% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >95%-100% reduction | 219 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >25%-30% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >50%-55% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >70%-75% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >75%-80% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >80%-85% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >65%-70% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >90%-95% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >85%-90% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >5%-10% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >70%-75% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | No reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >80%-85% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >75%-80% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >35%-40% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >50%-55% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >25%-30% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >40%-45% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >95%-100% reduction | 220 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >40%-45% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >50%-55% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >5%-10% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >55%-60% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >95%-100% reduction | 217 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >60%-65% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >90%-95% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >65%-70% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >85%-90% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >80%-85% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >70%-75% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | No reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >75%-80% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >30%-35% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >35%-40% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >25%-30% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | >20%-25% reduction | 0 participants |
Secondary
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time frame: Day 1 to Day 14-21
Population: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | No reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >50%-55% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >65%-70% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >70%-75% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >75%-80% reduction | 2 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >80%-85% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >85%-90% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >95%-100% reduction | 520 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >90%-95% reduction | 4 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Abscess, Placebo | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >70%-75% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >65%-70% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >20%-25% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | No reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >95%-100% reduction | 516 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >90%-95% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >50%-55% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >85%-90% reduction | 1 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >80%-85% reduction | 2 participants |
| Abscess, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >75%-80% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >50%-55% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >65%-70% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >10%-15% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >70%-75% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >75%-80% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >80%-85% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >85%-90% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >90%-95% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >95%-100% reduction | 191 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | No reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >25%-30% reduction | 1 participants |
| Infected Wound, TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >90%-95% reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >70%-75% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | No reduction | 1 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >95%-100% reduction | 199 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >65%-70% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >80%-85% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >75%-80% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >50%-55% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >85%-90% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Infected Wound, Clindamycin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >90%-95% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >70%-75% reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >75%-80% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >50%-55% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >80%-85% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >85%-90% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >5%-10% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >95%-100% reduction | 207 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | No reduction | 2 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >40%-45% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >65%-70% reduction | 1 participants |
| Cellulitis, Cephalexin and TMP/SMX | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >75%-80% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >40%-45% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >35%-40% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >80%-85% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >70%-75% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >20%-25% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >50%-55% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >55%-60% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >0%-5% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >25%-30% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >95%-100% reduction | 189 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >5%-10% reduction | 1 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >45%-50% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >15%-20% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >90%-95% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >60%-65% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | No reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >65%-70% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >85%-90% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >30%-35% reduction | 0 participants |
| Cellulitis, Cephalexin | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | >10%-15% reduction | 0 participants |