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

Not Applicable

Completed

• Conditions: HIV Infections; Staphylococcal Infections
• Interventions: Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%; Drug: Placebo

• Registration Number: NCT00631566
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2017-05
• Study Completion: 2017-10
• Results First Submitted: 2017-11-30
• Results First Submitted QC: 2018-07-18
• Results First Posted: 2018-08-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization	6 months	MRSA colonization at 6-months post-randomization

Secondary Outcome Measures

Name	Time	Method
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.	Every 6 months
To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.	At time of infection	This outcome measure was not analyzed/reported due to resource limitations.
To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.	at time of positive MRSA results	This outcome measure was not analyzed/reported due to resource limitation.

Trial Locations

Locations (4)

Naval Medical Center San Diego/Infectious Disease Division; 🇺🇸 San Diego, California, United States

San Antonio Military Medical Center (BAMC/WHMC); 🇺🇸 San Antonio, Texas, United States

Naval Medical Center Portsmouth; 🇺🇸 Portsmouth, Virginia, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States