An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers
Primary Purpose
Community-Acquired MRSA Infections, Abscesses, Cellulitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mupirocin (drug)
Sponsored by
About this trial
This is an interventional prevention trial for Community-Acquired MRSA Infections focused on measuring Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, MRSA, CA-MRSA
Eligibility Criteria
Inclusion Criteria:Soldiers enrolled into the combat medic course at Ft. Sam Houston, TX. - Exclusion Criteria: Allergy to mupirocin. -
Sites / Locations
- Brooke Army Medical Center
Outcomes
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).
Full Information
NCT ID
NCT00289588
First Posted
February 9, 2006
Last Updated
February 13, 2006
Sponsor
Brooke Army Medical Center
Collaborators
GlaxoSmithKline, Becton, Dickinson and Company
1. Study Identification
Unique Protocol Identification Number
NCT00289588
Brief Title
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers
Official Title
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus Infection in Soldiers: a Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Brooke Army Medical Center
Collaborators
GlaxoSmithKline, Becton, Dickinson and Company
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired MRSA Infections, Abscesses, Cellulitis, Folliculitis
Keywords
Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, MRSA, CA-MRSA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
3000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Mupirocin (drug)
Primary Outcome Measure Information:
Title
Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.
Secondary Outcome Measure Information:
Title
Changes in S. aureus carriage rates (including MRSA).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Soldiers enrolled into the combat medic course at Ft. Sam Houston, TX.
-
Exclusion Criteria: Allergy to mupirocin.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Ellis, MD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Ft. Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15472848
Citation
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.
Results Reference
background
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An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers
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