Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

Study Overview
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Brief Summary
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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.

Official Title
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Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute S. Aureus Skin and Skin Structure Infections in Patients With Comorbid Conditions: A Randomized Trial

Conditions
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Abscess, Skin Diseases, Bacterial

Intervention / Treatment
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* Biological: Linezolid
* Biological: Clindamycin


Participation Criteria
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Eligibility Criteria
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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: 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/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: linezolid<br> | Biological: Linezolid<br>* Linezolid 600 mg every 12 hours for 7 days<br>|
| Active Comparator: Clindamycin<br> | Biological: Clindamycin<br>* Clindamycin 300 mg po every 6 hours for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |