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

Primary Purpose

Skin Diseases, Bacterial, Abscess

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Linezolid
Clindamycin
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases, Bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grady Memorial Hospital
  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

linezolid

Clindamycin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 12, 2012
Last Updated
October 25, 2019
Sponsor
University of Chicago
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01619410
Brief Title
Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Bacterial, Abscess

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
linezolid
Arm Type
Active Comparator
Arm Title
Clindamycin
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Linezolid
Intervention Description
Linezolid 600 mg every 12 hours for 7 days
Intervention Type
Biological
Intervention Name(s)
Clindamycin
Intervention Description
Clindamycin 300 mg po every 6 hours for 7 days
Primary Outcome Measure Information:
Title
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
Description
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.
Time Frame
40 days after completion of treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days
Description
The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Time Frame
7 days after completion of treatment
Title
Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days
Description
The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
Time Frame
40 days after completion of treatment
Title
The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment
Description
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.
Time Frame
40 days after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Z David, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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

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