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

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

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.

Study Overview

• Status: Terminated
• Conditions: Abscess; Skin Diseases, Bacterial
• Intervention / Treatment: Biological: Linezolid; Biological: Clindamycin

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: linezolid	Biological: Linezolid; Linezolid 600 mg every 12 hours for 7 days
Active Comparator: Clindamycin	Biological: Clindamycin; Clindamycin 300 mg po every 6 hours for 7 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Pfizer
• Investigators: Principal Investigator: Michael Z David, MD, PhD, University of Chicago

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 14, 2012

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Asymptomatic Diseases; Skin Diseases; Asymptomatic Infections; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: 11-0550