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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Becton, Dickinson and Company
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00289588
First received: February 9, 2006
Last updated: February 13, 2006
Last verified: December 2005
History of Changes

February 9, 2006
February 13, 2006
January 2005
Not Provided
Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.
Same as current
Complete list of historical versions of study NCT00289588 on ClinicalTrials.gov Archive Site
Changes in S. aureus carriage rates (including MRSA).
Same as current
Not Provided
Not Provided
 
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus Infection in Soldiers: a Controlled Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Community-Acquired MRSA Infections
  • Abscesses
  • Cellulitis
  • Folliculitis
Drug: Mupirocin (drug)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
December 2005
Not Provided

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

-

Exclusion Criteria: Allergy to mupirocin.

-
Both
17 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00289588
C.2004.163
Not Provided
Not Provided
Brooke Army Medical Center
  • GlaxoSmithKline
  • Becton, Dickinson and Company
Principal Investigator: Michael W Ellis, MD Brooke Army Medical Center
Brooke Army Medical Center
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP