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Completed

NCT Number: NCT00631566

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

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.

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Key information

Conditions

HIV Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Staphylococcal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego/Infectious Disease Division, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%

Drug

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

Drug

Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.

Primary outcomes

  1. The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization

    Time frame: 6 months

    MRSA colonization at 6-months post-randomization

Secondary outcomes

  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

    This outcome measure was not analyzed/reported due to resource limitations.

  3. To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.

    Time frame: at time of positive MRSA results

    This outcome measure was not analyzed/reported due to resource limitation.

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

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

Registry information

Official study 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

Acronym: MRSA

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2008
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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