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

Henry M. Jackson Foundation for the Advancement of Military Medicine550 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

550

Conditions

HIV Infections Staphylococcal Infections

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (4)

Naval Medical Center San Diego/Infectious Disease Division

San Diego, California, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

San Antonio Military Medical Center (BAMC/WHMC)

San Antonio, Texas, United States

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Outcomes

Primary Outcomes

The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization

MRSA colonization at 6-months post-randomization

Time frame: 6 months

Secondary Outcomes

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.

This outcome measure was not analyzed/reported due to resource limitations.

Time frame: At time of infection

To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.

This outcome measure was not analyzed/reported due to resource limitation.

Time frame: at time of positive MRSA results