Randomized, Double-Blind, Placebo-Controlled Study on Decolonization Procedures for Methicillin-Resistant Staphylococcus aureus (MRSA) among HIV-Infected Adults

Amy Weintrob, Ionut Bebu, Brian Agan, Alona Diem, Erica Johnson, Tahaniyat Lalani, Xun Wang, Mary Bavaro, Michael Ellis, Katrin Mende, Nancy Crum-Cianflone, Amy Weintrob, Ionut Bebu, Brian Agan, Alona Diem, Erica Johnson, Tahaniyat Lalani, Xun Wang, Mary Bavaro, Michael Ellis, Katrin Mende, Nancy Crum-Cianflone

Abstract

Background: HIV-infected persons have increased risk of MRSA colonization and skin and soft-tissue infections (SSTI). However, no large clinical trial has examined the utility of decolonization procedures in reducing MRSA colonization or infection among community-dwelling HIV-infected persons.

Methods: 550 HIV-infected adults at four geographically diverse US military HIV clinics were prospectively screened for MRSA colonization at five body locations every 6 months during a 2-year period. Those colonized were randomized in a double-blind fashion to nasal mupirocin (Bactroban) twice daily and hexachlorophene (pHisoHex) soaps daily for 7 days compared to placeboes similar in appearance but without specific antibacterial activity. The primary endpoint was MRSA colonization at 6-months post-randomization; secondary endpoints were time to MRSA clearance, subsequent MRSA infections/SSTI, and predictors for MRSA clearance at the 6-month time point.

Results: Forty-nine (9%) HIV-infected persons were MRSA colonized and randomized. Among those with 6-month colonization data (80% of those randomized), 67% were negative for MRSA colonization in both groups (p = 1.0). Analyses accounting for missing 6-month data showed no significant differences could have been achieved. In the multivariate adjusted models, randomization group was not associated with 6-month MRSA clearance. The median time to MRSA clearance was similar in the treatment vs. placebo groups (1.4 vs. 1.8 months, p = 0.35). There was no difference on subsequent development of MRSA infections/SSTI (p = 0.89). In a multivariable model, treatment group, demographics, and HIV-specific factors were not predictive of MRSA clearance at the 6-month time point.

Conclusion: A one-week decolonization procedure had no effect on MRSA colonization at the 6-month time point or subsequent infection rates among community-dwelling HIV-infected persons. More aggressive or novel interventions may be needed to reduce the burden of MRSA in this population.

Trial registration: ClinicalTrials.gov NCT00631566.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow Diagram of Study Design,…
Fig 1. Flow Diagram of Study Design, Participation, and First-Time Randomizations.
Fig 2. Kaplan-Meier Curve for MRSA Clearance…
Fig 2. Kaplan-Meier Curve for MRSA Clearance among Randomized Participants.
Fig 3. Kaplan-Meier Curve for Time to…
Fig 3. Kaplan-Meier Curve for Time to SSTI among Randomized Participants.

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