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

NCT01619410 | Terminated Results

• 1 other identifier: 11-0550
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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.

  40 days after completion of treatment

Secondary Outcomes (3)

• Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days

  7 days after completion of treatment

• Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days

  40 days after completion of treatment

• The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment

  40 days after completion of treatment

Study Arms (2)

linezolid

ACTIVE COMPARATOR

Biological: Linezolid

Clindamycin

ACTIVE COMPARATOR

Biological: Clindamycin

Interventions

Linezolid BIOLOGICAL

Linezolid 600 mg every 12 hours for 7 days

linezolid

Clindamycin BIOLOGICAL

Clindamycin 300 mg po every 6 hours for 7 days

Clindamycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Pfizer: collaborator

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Skin Diseases, Bacterial; Abscess

Interventions

Linezolid; Clindamycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates

Limitations and Caveats

The anticipated enrollment of 152 subjects wasn't achieved. There was slower accrual because the epidemiology of S. aureus infections changed \& fewer eligible patients presented. Thus, the study is underpowered for the primary outcome.

Results Point of Contact

• Title: Michael Z. David/Assistant Professor
• Organization: University of Pennsylvania

michdav@pennmedicine.upenn.edu

215-662-6932

Study Officials

• Michael Z David, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 8, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-10

Locations

US (2)