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

H

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status

Completed

Conditions

Staphylococcal Infections
HIV Infections

Treatments

Drug: Placebo
Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%

Study type

Interventional

Funder types

Other
NETWORK
NIH

Identifiers

NCT00631566
IDCRP-003-RV210

Details and patient eligibility

About

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.

Enrollment

550 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

550 participants in 3 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
2
Placebo Comparator group
Treatment:
Drug: Placebo
No MRSA colonization
No Intervention group

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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