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

Sponsor:	Uniformed Services University of the Health Sciences
Collaborators:	Infectious Diseases Clinical Research Program National Institute of Allergy and Infectious Diseases (NIAID) US Military HIV Research Program
Information provided by:	Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:	NCT00631566

Purpose

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.

Condition	Intervention
HIV Infections Staphylococcal Infections	Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Staphylococcal Infections

Drug Information available for: Methicillin Hexachlorophene Mupirocin Mupirocin calcium Methicillin sodium Triclosan

U.S. FDA Resources

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population. [ Time Frame: at time of positive MRSA results ] [ Designated as safety issue: No ]

Estimated Enrollment:	550
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 hexachorophene (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.

Arms

Assigned Interventions

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 hexachorophene (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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631566

Locations

United States, California
Naval Medical Center San Diego/Infectious Disease Division
San Diego, California, United States, 92134-1201
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Texas
San Antonio Military Medical Center (BAMC/WHMC)
San Antonio, Texas, United States, 78236-9908
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708-2197

Sponsors and Collaborators

Uniformed Services University of the Health Sciences

Infectious Diseases Clinical Research Program

National Institute of Allergy and Infectious Diseases (NIAID)

US Military HIV Research Program

Investigators

Principal Investigator:

Amy Weintrob, MD

Infectious Disease Clinical Research Program (IDCRP)

More Information

No publications provided

Responsible Party:	Nancy Crum-Cianflone, MD, MPH, Infectious Diseases Clinical Research Program/Henry M. Jackson Foundation
ClinicalTrials.gov Identifier:	NCT00631566 History of Changes
Other Study ID Numbers:	IDCRP-003-RV210
Study First Received:	February 27, 2008
Last Updated:	August 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:

HIV
Methicillin-resistant Staphylococcus aureus (MRSA)
HIV and Staphylococcus aureus infection

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Staphylococcal Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Hexachlorophene

Triclosan
Methicillin
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012