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

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ClinicalTrials.gov Identifier: NCT00289588
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : February 16, 2006
Sponsor:
Collaborators:
GlaxoSmithKline
Becton, Dickinson and Company
Information provided by:
Brooke Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Community-Acquired MRSA Infections Abscesses Cellulitis Folliculitis Drug: Mupirocin (drug) Not Applicable

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  (Clinical Trial)
Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus Infection in Soldiers: a Controlled Trial
Study Start Date : January 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria: Allergy to mupirocin.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00289588     History of Changes
Other Study ID Numbers: C.2004.163
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: February 16, 2006
Last Verified: December 2005

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Cellulitis
Folliculitis
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Hair Diseases
Skin Diseases
Methicillin
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action