Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections
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.
Skin Diseases, Bacterial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The presence of Staphylococcus aureus after treatment with linezolid versus clindamycin [ Time Frame: 40 days after completion of treatment ] [ Designated as safety issue: No ]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.
- Clinical response of skin infections to treatment [ Time Frame: 7 days and 40 days after completion of treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 40 days after completion of treatment ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: linezolid||
Linezolid 600 mg every 12 hours for 7 days
|Active Comparator: Clindamycin||
Clindamycin 300 mg po every 6 hours for 7 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619410
|Contact: Michael Z David, MD||(773) email@example.com|
|United States, Georgia|
|Grady Memorial Hospital||Recruiting|
|Atlanta, Georgia, United States, 30303|
|Contact: Trisha Chan 404-702-2711 firstname.lastname@example.org|
|Contact: Lilly Immergluck 404 -756-1330 email@example.com|
|Principal Investigator: Lilly Immergluck, MD, MS|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Michael David, MD, PhD 773-702-3904 firstname.lastname@example.org|
|Principal Investigator: Michael David, MD, PhD|
|Principal Investigator:||Michael Z David, MD, PhD||University of Chicago|