Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
This study is ongoing, but not recruiting participants.
Sponsor:
Uniformed Services University of the Health Sciences
Collaborators:
Infectious Diseases Clinical Research Program
US Military HIV Research Program
Information provided by (Responsible Party):
Dr. Nancy Crum-Cianflone, Naval Health Research Center
ClinicalTrials.gov Identifier:
NCT00631566
First received: February 27, 2008
Last updated: January 18, 2013
Last verified: January 2013
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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
Drug Information available for:
Hexachlorophene
Triclosan
Mupirocin
Staphylococcus aureus
Mupirocin calcium
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: | December 2013 |
| 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.
|
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
US Military HIV Research Program
Investigators
| Principal Investigator: | Amy Weintrob, MD | Infectious Disease Clinical Research Program (IDCRP) |
More Information
No publications provided
| Responsible Party: | Dr. Nancy Crum-Cianflone, Department Head, US Department of Defense Center for Deployment Health Research, Naval Health Research Center |
| ClinicalTrials.gov Identifier: | NCT00631566 History of Changes |
| Other Study ID Numbers: | IDCRP-003-RV210 |
| Study First Received: | February 27, 2008 |
| Last Updated: | January 18, 2013 |
| 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 May 21, 2013