Clinical trial NCT01619410: 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
Overall status: TERMINATED
Phase: NA
Conditions: Skin Diseases, Bacterial
Abscess
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
timeFrame: 40 days after completion of treatment
Secondary outcomes:
measure: Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days
timeFrame: 7 days after completion of treatment
measure: Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days
timeFrame: 40 days after completion of treatment
measure: The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment
timeFrame: 40 days after completion of treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael Z David, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: