Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
Information source: Uniformed Services University of the Health Sciences
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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.
Eligibility
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.
Locations and Contacts
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
Alona Mask, B.A., Phone: 619-532-9812, Email: alona.mask@med.navy.mil
Nancy Crum-Cianflone, MD, MPH, Principal Investigator
Walter Reed Army Medical Center, Washington, District of Columbia 20307-5001, United States; Not yet recruiting
Terry Sjoberg, Phone: 202-782-8754, Email: terry.sjoberg@amedd.army.mil
COL Glenn Wortmann, MD, Principal Investigator
San Antonio Military Medical Center (BAMC/WHMC), San Antonio, Texas 78236-9908, United States; Not yet recruiting
Teresa Merritt, BS, Phone: 210-916-6011, Email: tmerritt@hjf.org
MAJ Michael Ellis, MD, Principal Investigator
Additional Information
Starting date: May 2007
Ending date: May 2011
Last updated: March 6, 2008
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