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

Not Applicable

Terminated

• Conditions: Abscess; Skin Diseases, Bacterial
• Interventions: Biological: Linezolid; Biological: Clindamycin

• Registration Number: NCT01619410
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2019-07-03
• Results First Submitted QC: 2019-07-03
• Results First Posted: 2019-07-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linezolid	Linezolid	-
Clindamycin	Clindamycin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States