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An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers
This study has been completed.
Sponsors and Collaborators: Brooke Army Medical Center
GlaxoSmithKline
Becton, Dickinson and Company
Information provided by: Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00289588
  Purpose

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.


Condition Intervention
Community-Acquired MRSA Infections
Abscesses
Cellulitis
Folliculitis
Drug: Mupirocin (drug)

MedlinePlus related topics: Cellulitis
Drug Information available for: Methicillin Mupirocin Mupirocin calcium Methicillin sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus Infection in Soldiers: a Controlled Trial

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.

Secondary Outcome Measures:
  • Changes in S. aureus carriage rates (including MRSA).

Estimated Enrollment: 3000
Study Start Date: January 2005
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   17 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

-

Exclusion Criteria: Allergy to mupirocin.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289588

Locations
United States, Texas
Brooke Army Medical Center
Ft. Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
GlaxoSmithKline
Becton, Dickinson and Company
Investigators
Principal Investigator: Michael W Ellis, MD Brooke Army Medical Center
  More Information

Publications:
Study ID Numbers: C.2004.163
Study First Received: February 9, 2006
Last Updated: February 13, 2006
ClinicalTrials.gov Identifier: NCT00289588  
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Methicillin-resistant Staphylococcus aureus
Staphylococcus aureus
MRSA
CA-MRSA

Study placed in the following topic categories:
Bacterial Infections
Mupirocin
Skin Diseases
Inflammation
Staphylococcal Infections
Cellulitis
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Methicillin
Abscess
Connective Tissue Diseases
Suppuration
Folliculitis

Additional relevant MeSH terms:
Hair Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009