Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
This trial is active, not recruiting.
|Conditions||hiv infections, staphylococcal infections|
|Treatments||mupirocin (bactroban) 2%; hexachlorophene (phisohex) 3%, placebo|
|Sponsor||Uniformed Services University of the Health Sciences|
|Collaborator||Infectious Diseases Clinical Research Program|
|Start date||May 2007|
|End date||December 2015|
|Trial size||550 participants|
|Trial identifier||NCT00631566, IDCRP-003-RV210|
This study will prospectively evaluate the prevalence and incidence (over a two year period) of MRSA colonization and infection among HIV-infected military beneficiaries to determine predictors for the development of MRSA colonization and infection. This study will also investigate the utility of decolonization procedures for clearance of MRSA carriage and prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial sensitivities of isolates in this population will be determined.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|San Diego, CA||Naval Medical Center San Diego/Infectious Disease Division||no longer recruiting|
|Bethesda, MD||Walter Reed National Military Medical Center||no longer recruiting|
|San Antonio, TX||San Antonio Military Medical Center (BAMC/WHMC)||no longer recruiting|
|Portsmouth, VA||Naval Medical Center Portsmouth||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
The presence of MRSA on repeated swabs to assess the efficacy of these medications on clearing MRSA colonization
time frame: Every 4 weeks for 5 months
To determine the prevalence and incidence of MRSA colonization of the nares, throat, perirectal, axilla, and groin areas among HIV infected patients and to study changes in the colonization rates over time.
time frame: Every 6 months
To evaluate the change in CD4 counts and HIV viral loads during the time of a MRSA or soft tissue infection.
time frame: At time of infection
To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population.
time frame: at time of positive MRSA results
Male or female participants at least 18 years old.
- Adults (at least 18 years of age) who are HIV positive by a reactive screening (ELISA, EIA) and a confirmatory test (Western blot) and who are able to attend the study visits which are every 6 months (+/- 2 months), at the minimum
- Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products.
- Age less than 18 years.
- Inability to remain in the study for the two year duration.
- Pregnant or breastfeeding females.
- Females who intend to become pregnant during the two year study time period.
- Persons who are healthcare providers with direct patient contact.
|Official title||Prospective Study on the Incidence, Predictors, and Characteristics of Methicillin-Resistant Staphylococcus Aureus Infections and a Randomized, Double-Blind Study on Decolonization Procedures for Prevention of MRSA Infections Among HIV-Infected Persons|
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