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

NCT ID: NCT00289588

Last Updated: 2006-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Community-Acquired MRSA Infections Abscesses Cellulitis Folliculitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Mupirocin (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

17 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Becton, Dickinson and Company

INDUSTRY

Sponsor Role collaborator

Brooke Army Medical Center

FED

Sponsor Role lead

Principal Investigators

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Michael W Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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Ellis MW, Hospenthal DR, Dooley DP, Gray PJ, Murray CK. Natural history of community-acquired methicillin-resistant Staphylococcus aureus colonization and infection in soldiers. Clin Infect Dis. 2004 Oct 1;39(7):971-9. doi: 10.1086/423965. Epub 2004 Sep 2.

Reference Type BACKGROUND
PMID: 15472848 (View on PubMed)

Other Identifiers

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C.2004.163

Identifier Type: -

Identifier Source: org_study_id