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Clinical Trials/NCT00289588
NCT00289588CompletedNot Applicable

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

Brooke Army Medical Center1 site in 1 country3,000 target enrollmentStarted: January 1, 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,000
Locations
1
Primary Endpoint
Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
17 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Soldiers enrolled into the combat medic course at Ft. Sam Houston, TX.

Exclusion Criteria

  • •Allergy to mupirocin.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Changes in S. aureus carriage rates (including MRSA).

Investigators

Sponsor Class
Fed

Study Sites (1)

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