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slow accrual
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linezolid | Active Comparator |
| |
| Clindamycin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Biological | Linezolid 600 mg every 12 hours for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 40 days after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days after completion of treatment |
| Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days |
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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:
Exclusion Criteria:
Other protocol related inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Z David, MD, PhD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| University of Chicago Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Linezolid | Linezolid: Linezolid 600 mg every 12 hours for 7 days |
| FG001 | Clindamycin | Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Linezolid | Linezolid: Linezolid 600 mg every 12 hours for 7 days |
| BG001 | Clindamycin | Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only subjects returning for the 40-day outcome measurement were included in this analysis | Posted | Count of Participants | Participants | 40 days after completion of treatment |
|
40 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Linezolid | Linezolid: Linezolid 600 mg every 12 hours for 7 days | 0 |
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The anticipated enrollment of 152 subjects wasn't achieved. There was slower accrual because the epidemiology of S. aureus infections changed & fewer eligible patients presented. Thus, the study is underpowered for the primary outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Z. David/Assistant Professor | University of Pennsylvania | 215-662-6932 | michdav@pennmedicine.upenn.edu |
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| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D000038 | Abscess |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Clindamycin |
| Biological |
Clindamycin 300 mg po every 6 hours for 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. |
| 40 days after completion of treatment |
| 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. | 40 days after completion of treatment |
| Chicago |
| Illinois |
| 60637 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Count of Participants | Participants | 7 days after completion of treatment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 40 days after completion of treatment |
|
|
|
| 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. | No data available due to samples being lost as a result of equipment issues. | Posted | 40 days after completion of treatment |
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Clindamycin | Clindamycin: Clindamycin 300 mg po every 6 hours for 7 days | 0 | 11 | 0 | 11 | 0 | 11 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Relapse |
|
| Relapse |
|