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

Cellulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289588
• Other study ID #: C.2004.163
• Status: Completed
• Phase: N/A
• First received: February 9, 2006
• Last updated: February 13, 2006
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: December 2005
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 60 Years

Eligibility

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

Exclusion Criteria: Allergy to mupirocin.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abscesses
• Cellulitis
• Community-Acquired MRSA Infections
• Folliculitis
• Infection
• Staphylococcal Infections

Intervention

Drug:
• Mupirocin (drug)

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Ft. Sam Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Becton, Dickinson and Company, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2004 Sep 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.
Secondary	Changes in S. aureus carriage rates (including MRSA).