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Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons

Information source: Uniformed Services University of the Health Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Staphylococcal Infections

Intervention: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% (Drug); Placebo (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Uniformed Services University of the Health Sciences


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The presence of MRSA on repeated swabs to assess the efficacy of these medications on clearing MRSA colonization

Secondary outcome:

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.

To evaluate the change in CD4 counts and HIV viral loads during the time of a MRSA or soft tissue infection.

To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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 Exclusion Criteria:

- 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.

Locations and Contacts

Naval Medical Center San Diego/Infectious Disease Division, San Diego, California 92134-1201, United States

Walter Reed National Military Medical Center, Bethesda, Maryland 20889, United States

San Antonio Military Medical Center (BAMC/WHMC), San Antonio, Texas 78236-9908, United States

Naval Medical Center Portsmouth, Portsmouth, Virginia 23708-2197, United States

Additional Information

Starting date: May 2007
Last updated: May 7, 2015

Page last updated: August 23, 2015

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