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

This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Michael David, University of Chicago
ClinicalTrials.gov Identifier:
NCT01619410
First received: June 12, 2012
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Skin Diseases, Bacterial
Abscess
 Biological: Linezolid
Biological: Clindamycin

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 152
Study Start Date: January 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619410

Contacts
Contact: Michael Z David, MD (773) 702-3904 mdavid@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael David, MD, PhD     773-702-3904     mdavid@medicine.bsd.uchicago.edu    
Principal Investigator: Michael David, MD, PhD            
Sponsors and Collaborators
University of Chicago
Pfizer
Investigators
Principal Investigator: Michael Z David, MD, PhD University of Chicago
  More Information

No publications provided

Responsible Party: Michael David, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01619410     History of Changes
Other Study ID Numbers: 11-0550
Study First Received: June 12, 2012
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Skin Diseases, Infectious
Abscess
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Infection
Inflammation
Pathologic Processes
Bacterial Infections
Clindamycin
 Linezolid
Clindamycin-2-phosphate
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013