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

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ClinicalTrials.gov Identifier: NCT00631566
Recruitment Status : Active, not recruiting
First Posted : March 7, 2008
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Information provided by (Responsible Party):
Brian Agan, Uniformed Services University of the Health Sciences

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.

Condition or disease Intervention/treatment Phase
HIV Infections Staphylococcal Infections Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2007
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS MRSA
U.S. FDA Resources

Arm Intervention/treatment
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 hexachlorophene (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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To characterize the molecular characteristics and the antimicrobial sensitivities of MRSA isolates in this population. [ Time Frame: at time of positive MRSA results ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631566


Locations
United States, California
Naval Medical Center San Diego/Infectious Disease Division
San Diego, California, United States, 92134-1201
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
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
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program

Publications of Results:
Responsible Party: Brian Agan, Deputy Science Director, IDCRP, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT00631566     History of Changes
Other Study ID Numbers: IDCRP-003-RV210
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Brian Agan, Uniformed Services University of the Health Sciences:
HIV
Methicillin-resistant Staphylococcus aureus (MRSA)
HIV and Staphylococcus aureus infection

Additional relevant MeSH terms:
HIV Infections
Infection
Communicable Diseases
Staphylococcal Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Mupirocin
Hexachlorophene
Triclosan
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents