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

February 14, 2013 updated by: Joseph Kim

Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
OTHER: education
No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning
Behavioral: Education
No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eradication of MRSA carriage
Time Frame: 90 days after randomization
90 days after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of MRSA infection
Time Frame: Within 6 months of randomization
Within 6 months of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Kim

Collaborators

Alberta Health services

Investigators

  • Principal Investigator: Thomas J Louie, MD, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E23134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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