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

Condition(s) targeted: HIV Infections; Staphylococcal Infections

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

Phase: N/A

Status: Recruiting

Sponsored by: Uniformed Services University of the Health Sciences

Official(s) and/or principal investigator(s):
Nancy Crum-Cianflone, MD, MPH, Principal Investigator, Affiliation: Infectious Disease Clinical Research Program (IDCRP)/Tri-Service AIDS Research Clinical Consortium (TACC)

Overall contact:
Nancy Crum-Cianflone, MD, Phone: 619-532-7475, Email: nancy.crum@med.navy.mil

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.

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The presence of MRSA on repeated swabs to assess the efficacy of these medications on clearing MRSA colonization

Secondary outcome:

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.

To evaluate the change in CD4 counts and HIV viral loads during the time of a MRSA or soft tissue infection.

To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Nancy Crum-Cianflone, MD, Phone: 619-532-7475, Email: nancy.crum@med.navy.mil

Naval Medical Center San Diego/Infectious Disease Division, San Diego, California 92134-1201, United States; Recruiting
Sheila Medina, MPH, Phone: 619-532-7817, Email: sheila.medina@med.navy.mil
Nancy Crum-Cianflone, MD, MPH, Principal Investigator

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5001, United States; Recruiting
David Wallace, Phone: 202-782-8754, Email: david.wallace@amedd.army.mil
COL Glenn Wortmann, MD, Principal Investigator

San Antonio Military Medical Center (BAMC/WHMC), San Antonio, Texas 78236-9908, United States; Recruiting
Terry Sjoberg, Phone: 210-916-0861, Email: terry.sjoberg@amedd.army.mil
COL Duane Hospenthal, MD, Principal Investigator

Naval Medical Center Portsmouth, Portsmouth, Virginia 23708-2197, United States; Recruiting
Roneke D Cole, Phone: 757-953-1970, Email: roneke.cole@med.navy.mil
CDR Jason Maguire, MD, Principal Investigator

Starting date: May 2007
Last updated: May 13, 2010