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

This study is ongoing, but not recruiting participants.
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Information provided by (Responsible Party):
Brian Agan, Uniformed Services University of the Health Sciences Identifier:
First received: February 27, 2008
Last updated: May 10, 2016
Last verified: May 2016
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.

Condition Intervention
HIV Infections
Staphylococcal Infections
Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
Drug: Placebo

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

Resource links provided by NLM:

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population. [ Time Frame: at time of positive MRSA results ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: May 2007
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%

BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).

pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.

Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.

Placebo Comparator: 2 Drug: Placebo
Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00631566

United States, California
Naval Medical Center San Diego/Infectious Disease Division
San Diego, California, United States, 92134-1201
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Texas
San Antonio Military Medical Center (BAMC/WHMC)
San Antonio, Texas, United States, 78236-9908
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
  More Information

Responsible Party: Brian Agan, Deputy Science Director, IDCRP, Uniformed Services University of the Health Sciences Identifier: NCT00631566     History of Changes
Other Study ID Numbers: IDCRP-003-RV210 
Study First Received: February 27, 2008
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Uniformed Services University of the Health Sciences:
Methicillin-resistant Staphylococcus aureus (MRSA)
HIV and Staphylococcus aureus infection

Additional relevant MeSH terms:
Communicable Diseases
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors processed this record on May 25, 2016