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Trial record 1 of 1 for:    NCT01619410
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Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

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ClinicalTrials.gov Identifier: NCT01619410
Recruitment Status : Terminated (slow accrual)
First Posted : June 14, 2012
Results First Posted : July 24, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 14, 2012
Results First Submitted Date  ICMJE July 3, 2019
Results First Posted Date  ICMJE July 24, 2019
Last Update Posted Date November 8, 2019
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
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 [ Time Frame: 40 days after completion of therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
To assess the efficacy of a 7-day course of linezolid vs. clindamycin in the empiric therapy as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses. [ Time Frame: 40 days after completion of therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Diseases, Bacterial
  • Abscess
Intervention  ICMJE
  • Biological: Linezolid
    Linezolid 600 mg every 12 hours for 7 days
  • Biological: Clindamycin
    Clindamycin 300 mg po every 6 hours for 7 days
Study Arms  ICMJE
  • Active Comparator: linezolid
    Intervention: Biological: Linezolid
  • Active Comparator: Clindamycin
    Intervention: Biological: Clindamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 3, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
152
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01619410
Other Study ID Numbers  ICMJE 11-0550
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Michael Z David, MD, PhD University of Chicago
PRS Account University of Chicago
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP