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

Tracking Information

First Received Date ^ICMJE

February 27, 2008

Last Updated Date

April 24, 2009

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00631566 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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: During entire study duration ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infections
Staphylococcal Infections

Intervention ^ICMJE

Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

550

Estimated Completion Date

May 2011

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nancy Crum-Cianflone, MD

619-532-7475

nancy.crum@med.navy.mil

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00631566

Responsible Party

Nancy Crum-Cianflone, MD, MPH, Infectious Diseases Clinical Research Program/Henry M. Jackson Foundation

Study ID Numbers ^ICMJE

IDCRP-003-RV210

Study Sponsor ^ICMJE

Uniformed Services University of the Health Sciences

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Nancy Crum-Cianflone, MD, MPH

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

Information Provided By

Uniformed Services University of the Health Sciences

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP