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

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
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% Other: Placebo

MedlinePlus related topics: AIDS Staphylococcal Infections

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Placebo Comparator	Other: 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

1: Experimental

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.

2: Placebo Comparator

Other: 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

Contacts

Contact: Nancy Crum-Cianflone, MD

619-532-7475

nancy.crum@med.navy.mil

Locations

United States, California
Naval Medical Center San Diego/Infectious Disease Division	Recruiting
San Diego, California, United States, 92134-1201
Contact: Alona Mask, B.A. 619-532-9812 alona.mask@med.navy.mil
Principal Investigator: Nancy Crum-Cianflone, MD, MPH
United States, District of Columbia
Walter Reed Army Medical Center	Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: David Wallace 202-782-8754 david.wallace@amedd.army.mil
Principal Investigator: COL Glenn Wortmann, MD
United States, Texas
San Antonio Military Medical Center (BAMC/WHMC)	Recruiting
San Antonio, Texas, United States, 78236-9908
Contact: Terry Sjoberg 210-916-0861 terry.sjoberg@amedd.army.mil
Principal Investigator: MAJ Michael Ellis, MD

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:

Nancy Crum-Cianflone, MD, MPH

Infectious Disease Clinical Research Program (IDCRP)/Tri-Service AIDS Research Clinical Consortium (TACC)

More Information

No publications provided

Responsible Party:	Infectious Diseases Clinical Research Program/Henry M. Jackson Foundation ( Nancy Crum-Cianflone, MD, MPH )
Study ID Numbers:	IDCRP-003-RV210
Study First Received:	February 27, 2008
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00631566 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Bacterial Infections
Sexually Transmitted Diseases, Viral
Mupirocin
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Anti-Infective Agents, Local
Calcium, Dietary

Staphylococcal Infections
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Glycerol
Methicillin
Hexachlorophene
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections
Triclosan

Additional relevant MeSH terms:

Bacterial Infections
Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Methicillin
Therapeutic Uses
Retroviridae Infections
RNA Virus Infections
Mupirocin

Immune System Diseases
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Staphylococcal Infections
HIV Infections
Hexachlorophene
Sexually Transmitted Diseases
Lentivirus Infections
Triclosan

ClinicalTrials.gov processed this record on May 07, 2009