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

NCT ID: NCT01619410

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Skin Diseases, Bacterial; Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

linezolid

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: BIOLOGICAL

Linezolid 600 mg every 12 hours for 7 days

Clindamycin

Group Type: ACTIVE_COMPARATOR

Clindamycin

Intervention Type: BIOLOGICAL

Clindamycin 300 mg po every 6 hours for 7 days

Interventions

Linezolid

Linezolid 600 mg every 12 hours for 7 days

Intervention Type: BIOLOGICAL

Clindamycin

Clindamycin 300 mg po every 6 hours for 7 days

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Z David, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

11-0550

Identifier Type: -

Identifier Source: org_study_id