An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers

February 13, 2006 updated by: Brooke Army Medical Center

An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus Infection in Soldiers: a Controlled Trial

The main purpose of this study is to determine if applying mupirocin into soldiers noses who are colonized with methicillin-resistant Staphylococcus aureus (MRSA) will reduce infections in them and their cohort of fellow soldiers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Community-acquired MRSA infections are increasingly common in the community and in particular among certain groups of which soldiers are one. Many researchers and clinicians have postulated that one method to prevent infections is to selectively eradicate CA-MRSA in those who are colonized with the pathogen. The two main purposes of the study are: to determine if selective CA-MRSA eradication in subjects reduces infections in the CA-MRSA colonized individual; and to determine if selective CA-MRSA eradication in subjects reduces infections in the study cohort. Other information concerning CA-MRSA includes: prevalence, risk factors, and virulence data. The population will be soldiers enrolled in the combat medic training class at Ft. Sam Houston. We will enroll approximately 3000 soldiers over a two year period. After informed written consent, we will culture their anterior nares nares and administer questionnaires at the beginning and at the end of the study, following them prospectively for infections. The follow-up period will be 16 weeks. For those with CA-MRSA in their nares, they will be randomized (by cohort) to receive either 5 days of mupirocin or placebo.

Study Type

Interventional

Enrollment

3000

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

  • United States
    • Texas
      • Ft. Sam Houston, Texas, United States, 78234
        • Brooke Army 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

17 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:Soldiers enrolled into the combat medic course at Ft. Sam Houston, TX.

-

Exclusion Criteria: Allergy to mupirocin.

-

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.

Secondary Outcome Measures

Outcome Measure
Changes in S. aureus carriage rates (including MRSA).

Collaborators and Investigators

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

Sponsor

Brooke Army Medical Center

Collaborators

GlaxoSmithKline
Becton, Dickinson and Company

Investigators

  • Principal Investigator: Michael W Ellis, MD, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

February 16, 2006

Last Update Submitted That Met QC Criteria

February 13, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2004.163

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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