Abscess, Skin Diseases, Bacterial
Conditions
Brief summary
In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.
Interventions
BIOLOGICALLinezolid
Linezolid 600 mg every 12 hours for 7 days
BIOLOGICALClindamycin
Clindamycin 300 mg po every 6 hours for 7 days
Sponsors
Pfizer
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* having an ABSSSI or a minor cutaneous abscess treated in the ED * age 18 years or older * any one or more of the following co-morbidities: * diagnosis of diabetes mellitus * obesity with a BMI \>35 * chronic kidney disease * coronary artery disease * peripheral vascular disease
Exclusion criteria
* known history of or current thrombocytopenia * Currently taking anti-depression medication * Current or recent hospitalization * Known current alcohol or drug abuse * Known or suspected hypersensitivity to any ingredient of the study drugs * Irregular heart rate and blood pressure measurements * Fevers or low body temperature * Known psychiatric condition * Superficial skin infection * Skin infection caused from an animal bite * Recent treatment with antibacterials * Pregnancy Other protocol related inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin | 40 days after completion of treatment | Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | 7 days after completion of treatment | The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse. |
| Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | 40 days after completion of treatment | The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse. |
| The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment | 40 days after completion of treatment | The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Linezolid Linezolid: Linezolid 600 mg every 12 hours for 7 days | 14 |
| Clindamycin Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 4 |
Baseline characteristics
| Characteristic | Linezolid | Total | Clindamycin |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 15.4 | 42.0 years STANDARD_DEVIATION 13.8 | 40.5 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 25 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 24 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 25 participants | 11 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 11 |
| other Total, other adverse events | 0 / 14 | 0 / 11 |
| serious Total, serious adverse events | 0 / 14 | 0 / 11 |
Outcome results
Primary
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.
Time frame: 40 days after completion of treatment
Population: Only subjects returning for the 40-day outcome measurement were included in this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Linezolid | Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin | 3 Participants |
| Clindamycin | Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin | 2 Participants |
p-value: 1Fisher Exact
Secondary
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days
The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Time frame: 40 days after completion of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Linezolid | Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | Cure | 9 Participants |
| Linezolid | Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | Treatment failure | 0 Participants |
| Linezolid | Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | Relapse | 0 Participants |
| Clindamycin | Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | Cure | 6 Participants |
| Clindamycin | Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | Treatment failure | 0 Participants |
| Clindamycin | Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days | Relapse | 1 Participants |
Secondary
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days
The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Time frame: 7 days after completion of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Linezolid | Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | Cure | 10 Participants |
| Linezolid | Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | Treatment failure | 0 Participants |
| Linezolid | Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | Relapse | 0 Participants |
| Clindamycin | Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | Cure | 7 Participants |
| Clindamycin | Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | Treatment failure | 0 Participants |
| Clindamycin | Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days | Relapse | 0 Participants |
Secondary
The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment
The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups.
Time frame: 40 days after completion of treatment
Population: No data available due to samples being lost as a result of equipment issues.