Clinical trial NCT00289588: 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
Overall status: COMPLETED
Phase: NA
Conditions: Community-Acquired MRSA Infections
Abscesses
Cellulitis
Folliculitis
Keywords: Methicillin-resistant Staphylococcus aureus
Staphylococcus aureus
MRSA
CA-MRSA
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
name: Becton, Dickinson and Company
First posted: 2006-02-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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Exclusion Criteria: Allergy to mupirocin.

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Primary outcomes:
measure: Soft tissue infections in subjects who received the study medication and soft tissue infections in the study cohorts.
Secondary outcomes:
measure: Changes in S. aureus carriage rates (including MRSA).
Other outcomes:
Locations:
city: Ft. Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Michael W Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.