N/A
N=550
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
HIV Infections · Staphylococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00631566 ↗Enrolled (actual)
550
Serious AEs
0.2%
Results posted
Aug 2018
Primary outcome: Primary: The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization — 12; 14; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization |
12; 14; 0 | — |
| SECONDARY 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. |
17; 18; 0; NA; NA; 0 | — |
| SECONDARY To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection. |
— | — |
| SECONDARY To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population. |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00631566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.