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

The University of Chicago

Status: Terminated

Conditions: Skin Diseases, Bacterial; Abscess

Treatments: Biological: Clindamycin; Biological: Linezolid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01619410

11-0550

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

linezolid

Active Comparator group

Treatment:

Biological: Linezolid

Clindamycin

Active Comparator group

Treatment:

Biological: Clindamycin