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

NCT01619410

Last updated date
Study Location
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Skin Diseases, Abscess
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pfizer Clinical Trials Contact Center

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[email protected]

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Bacterial Skin Diseases, AbscessAsymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections
NCT01619410
  1. Atlanta, Georgia
  2. Chicago, Illinois
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, PhDUniversity 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