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

March 1, 2023 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134-1201
        • Naval Medical Center San Diego/Infectious Disease Division
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Texas
      • San Antonio, Texas, United States, 78236-9908
        • San Antonio Military Medical Center (BAMC/WHMC)
    • Virginia
      • Portsmouth, Virginia, United States, 23708-2197
        • Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
No Intervention: No MRSA colonization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
Time Frame: 6 months
MRSA colonization at 6-months post-randomization
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
This outcome measure was not analyzed/reported due to resource limitations.
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
This outcome measure was not analyzed/reported due to resource limitation.
at time of positive MRSA results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Infectious Diseases Clinical Research Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCRP-003-RV210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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