Bacterial Infections
Conditions
Brief summary
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.
Detailed description
Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section. ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid
Interventions
DRUGTedizolid (BAY119-2631)
50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days
DRUGPlacebo Tedizolid (BAY119-2631)
50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days
DRUGLinezolid
50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days
50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days
Sponsors
Merck Sharp & Dohme LLC
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females \>/=18 years old * Adequate venous access for a minimum of 2 I.V. doses of study drug * Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit * Cellulitis/erysipelas * Major cutaneous abscess * Wound Infection * Suspected or documented gram-positive infection from baseline Gram stain or culture.
Exclusion criteria
* Uncomplicated skin and skin structure infections such as furuncles, minor abscesses * Infections associated with, or in close proximity to, a prosthetic device * Severe sepsis or septic shock * Known bacteremia at time of screening * ABSSSI due to or associated with any of the following: * Suspected or documented gram-negative pathogens in patients with cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with specific gram-negative coverage. Patients with wound infections where gram-negative adjunctive therapy is warranted may be enrolled if they meet the other eligibility criteria * Diabetic foot infections, gangrene, or perianal abscess * Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis) * Infected burns * Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous) * Any evolving necrotizing process (ie, necrotizing fasciitis) * Use of antibiotics as follows: * Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 24 hours before the first infusion of study drug * Patients who failed prior therapy for the primary infection site are also excluded from enrollment * Topical antibiotic on the primary lesion within 24 hours before the first infusion of study drug except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound * Administration of Linezolid within 30 days before the first infusion of the study drug * Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome \[AIDS\]) * Previous exposure to Tedizolid Phosphate treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Baseline and 48-72 hours visit | Early clinical response is defined as responder if there is \>=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Baseline and EOT visit (Day 11) | Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate. |
| Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Baseline and post-therapy evaluation visit (7-14 days after Day 11) | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. |
| Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Baseline and post-therapy evaluation visit (7-14 days after Day 11) | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. |
| Investigator's Assessment of Clinical Response at 48-72 Hours | Baseline and at 48-72 hours | The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other. |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Baseline and EOT visit (Day 11) | Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48-72 H Visit. |
| Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. |
| Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. |
| Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. |
| Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. |
| Investigator's Assessment of Clinical Response at Day 7 Visit | Baseline and Day 7 visit | The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other. |
Countries
China, Philippines, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo | 300 |
| Linezolid Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days | 298 |
| Total | 598 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 11 | 8 |
| Overall Study | Progressive disease-clinical progression | 0 | 1 |
| Overall Study | Protocol driven decision point | 0 | 1 |
| Overall Study | Withdrawal by Subject | 14 | 11 |
Baseline characteristics
| Characteristic | Tedizolid Phosphate (Sivextro, BAY119-2631) | Linezolid | Total |
|---|---|---|---|
| Age, Customized 65 - 75 years | 33 Participants | 35 Participants | 68 Participants |
| Age, Customized < 65 years | 259 Participants | 245 Participants | 504 Participants |
| Age, Customized > 75 years | 8 Participants | 18 Participants | 26 Participants |
| Sex: Female, Male Female | 91 Participants | 106 Participants | 197 Participants |
| Sex: Female, Male Male | 209 Participants | 192 Participants | 401 Participants |
| Type of acute bacterial skin and skin structure infections (ABSSSI) infection Cellulitis/erysipelas | 192 Participants | 191 Participants | 383 Participants |
| Type of acute bacterial skin and skin structure infections (ABSSSI) infection Major cutaneous abscess | 40 Participants | 39 Participants | 79 Participants |
| Type of acute bacterial skin and skin structure infections (ABSSSI) infection Wound infection | 68 Participants | 68 Participants | 136 Participants |
| Visual analog scale (VAS) pain scores | 53.2 Units on a scale STANDARD_DEVIATION 27.3 | 53.9 Units on a scale STANDARD_DEVIATION 28.7 | 53.6 Units on a scale STANDARD_DEVIATION 28 |
| Wong-Baker faces rating scale (FRS) pain scores | 5.6 Units on a scale STANDARD_DEVIATION 2.6 | 5.7 Units on a scale STANDARD_DEVIATION 2.7 | 5.6 Units on a scale STANDARD_DEVIATION 2.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 292 | 63 / 297 |
| serious Total, serious adverse events | 11 / 292 | 8 / 297 |
Outcome results
Primary
Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
Early clinical response is defined as responder if there is \>=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.
Time frame: Baseline and 48-72 hours visit
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | 75.3 Percentage of participants |
| Linezolid | Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | 79.9 Percentage of participants |
p-value: 0.202795% CI: [-11.2, 2.2]Fisher Exact
Secondary
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.
Time frame: Up to EOT visit (Day 11)
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 2 | -1.5 Units on a scale | Standard Deviation 2 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | 48-72 hours | -2.4 Units on a scale | Standard Deviation 2.2 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 7 | -3.5 Units on a scale | Standard Deviation 2.6 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | EOT | -4.2 Units on a scale | Standard Deviation 2.8 |
| Linezolid | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | EOT | -4.4 Units on a scale | Standard Deviation 2.7 |
| Linezolid | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 2 | -1.5 Units on a scale | Standard Deviation 1.8 |
| Linezolid | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 7 | -3.6 Units on a scale | Standard Deviation 2.5 |
| Linezolid | Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point | 48-72 hours | -2.4 Units on a scale | Standard Deviation 2.3 |
Secondary
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.
Time frame: Up to EOT visit (Day 11)
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 2 | -12.5 Units on a scale | Standard Deviation 21.7 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | 48-72 hours | -23.2 Units on a scale | Standard Deviation 23.9 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 7 | -34.7 Units on a scale | Standard Deviation 26.7 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | EOT | -41.6 Units on a scale | Standard Deviation 28.3 |
| Linezolid | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | EOT | -43.6 Units on a scale | Standard Deviation 29.1 |
| Linezolid | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 2 | -13.8 Units on a scale | Standard Deviation 20.1 |
| Linezolid | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 7 | -36.1 Units on a scale | Standard Deviation 26.7 |
| Linezolid | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | 48-72 hours | -23.2 Units on a scale | Standard Deviation 24.3 |
Secondary
Investigator's Assessment of Clinical Response at 48-72 Hours
The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.
Time frame: Baseline and at 48-72 hours
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at 48-72 Hours | Stable | 4.7 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at 48-72 Hours | Improving | 86.7 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at 48-72 Hours | Other | 0.7 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at 48-72 Hours | Missing | 8.0 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at 48-72 Hours | Missing | 6.7 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at 48-72 Hours | Other | 0.0 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at 48-72 Hours | Improving | 90.3 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at 48-72 Hours | Stable | 3.0 Percentage of participants |
Secondary
Investigator's Assessment of Clinical Response at Day 7 Visit
The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.
Time frame: Baseline and Day 7 visit
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at Day 7 Visit | Improving | 88.3 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at Day 7 Visit | Other | 0.3 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Investigator's Assessment of Clinical Response at Day 7 Visit | Missing | 11.3 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at Day 7 Visit | Improving | 87.6 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at Day 7 Visit | Other | 0.3 Percentage of participants |
| Linezolid | Investigator's Assessment of Clinical Response at Day 7 Visit | Missing | 12.1 Percentage of participants |
Secondary
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set
The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.
Time frame: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Population: CE-PTE
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Clinical success | 90.4 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Clinical failure or Indeterminate | 9.6 Percentage of participants |
| Linezolid | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Clinical success | 93.5 Percentage of participants |
| Linezolid | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Clinical failure or Indeterminate | 6.5 Percentage of participants |
95% CI: [-8.4, 2]
Secondary
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.
Time frame: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Clinical success | 79.7 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Clinical failure or Indeterminate | 20.3 Percentage of participants |
| Linezolid | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Clinical success | 81.9 Percentage of participants |
| Linezolid | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Clinical failure or Indeterminate | 18.1 Percentage of participants |
95% CI: [-8.6, 4.1]
Secondary
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
Time frame: Baseline and EOT visit (Day 11)
Population: CE-EOT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Clinical success | 89.7 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Clinical failure or Indeterminate | 10.3 Percentage of participants |
| Linezolid | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Clinical success | 91.8 Percentage of participants |
| Linezolid | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Clinical failure or Indeterminate | 8.2 Percentage of participants |
95% CI: [-7.4, 3.2]
Secondary
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48-72 H Visit.
Time frame: Baseline and EOT visit (Day 11)
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Clinical success | 82.0 Percentage of participants |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Clinical failure or Indeterminate | 18.0 Percentage of participants |
| Linezolid | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Clinical success | 84.2 Percentage of participants |
| Linezolid | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Clinical failure or Indeterminate | 15.8 Percentage of participants |
95% CI: [-8.3, 3.8]
Secondary
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.
Time frame: Up to EOT visit (Day 11)
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 2 | 4.1 Units on a scale | Standard Deviation 2.4 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | 48-72 hours | 3.2 Units on a scale | Standard Deviation 2.4 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 7 | 2.1 Units on a scale | Standard Deviation 2.3 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | EOT | 1.3 Units on a scale | Standard Deviation 2 |
| Linezolid | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | EOT | 1.3 Units on a scale | Standard Deviation 1.9 |
| Linezolid | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 2 | 4.2 Units on a scale | Standard Deviation 2.5 |
| Linezolid | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Day 7 | 2.0 Units on a scale | Standard Deviation 2.2 |
| Linezolid | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | 48-72 hours | 3.2 Units on a scale | Standard Deviation 2.5 |
Secondary
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.
Time frame: Up to EOT visit (Day 11)
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 2 | 40.9 Units on a scale | Standard Deviation 26.3 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | 48-72 hours | 30.2 Units on a scale | Standard Deviation 25.6 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 7 | 18.8 Units on a scale | Standard Deviation 22.9 |
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | EOT | 11.6 Units on a scale | Standard Deviation 19.4 |
| Linezolid | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | EOT | 10.3 Units on a scale | Standard Deviation 18.1 |
| Linezolid | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 2 | 40.1 Units on a scale | Standard Deviation 26.5 |
| Linezolid | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Day 7 | 17.8 Units on a scale | Standard Deviation 21.2 |
| Linezolid | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | 48-72 hours | 30.7 Units on a scale | Standard Deviation 25.7 |