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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

• 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 hexachorophene (pHisoHex) body washes for seven days.
• Other: Placebo
  • Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary 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
    Safety Issue?: No

Secondary 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
    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
    Safety Issue?: No
• To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population.
  • Time Frame: During entire study duration
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Uniformed Services University of the Health Sciences

Overall Clinical Trial Officials and Contacts

Nancy Crum-Cianflone, MD, MPH Principal Investigator Infectious Disease Clinical Research Program (IDCRP)/Tri-Service AIDS Research Clinical Consortium (TACC)  

Overall Contact: Nancy Crum-Cianflone, MD 619-532-7475 nancy.crum@med.navy.mil

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631566

Study ID Number: IDCRP-003-RV210

ClinicalTrials.gov Identifier: NCT00631566

Health Authority: United States: Institutional Review Board