Overview

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

Summary

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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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)
placebo
Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences.