Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting

Overview

The purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. We hypothesize that a greater proportion of those who receive intervention will eliminate MRSA carriage compared to those who do not receive any intervention.

Full Title of Study: “Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

Interventions

  • Drug: pharmacological decolonization treatment
    • Chlorhexidine gluconate 4% body scrub and 2% shampoo daily PLUS mupirocin 2%, fusidic acid 2%, or chlorhexidine gluconate 0.2% intranasally bid PLUS trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days
  • Behavioral: Education
    • No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning

Arms, Groups and Cohorts

  • Active Comparator: decolonization treatment
    • topical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning
  • Other: education
    • No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning

Clinical Trial Outcome Measures

Primary Measures

  • Eradication of MRSA carriage
    • Time Frame: 90 days after randomization

Secondary Measures

  • Occurrence of MRSA infection
    • Time Frame: Within 6 months of randomization

Participating in This Clinical Trial

Inclusion Criteria

  • Prior MRSA infection (i.e index case)
  • Identified as being colonized with MRSA on initial screen

Exclusion Criteria

  • Are pregnant or breastfeeding.
  • Have indwelling catheters.
  • Received prior decolonization treatment within last 6 months of enrollment.
  • Have allergy to study medication.
  • Are colonized with MRSA strain resistant to study medication.
  • Have active infection requiring systemic antimicrobials.
  • Are household contacts to index case.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Joseph Kim
  • Collaborator
    • Alberta Health Services
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Joseph Kim, Clinical Assistant Professor – University of Calgary
  • Overall Official(s)
    • Thomas J Louie, MD, Principal Investigator, University of Calgary

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