title: Randomized, Double-Blind, Placebo-Controlled Study on Decolonization Procedures for Methicillin-Resistant Staphylococcus aureus (MRSA) among HIV-Infected Adults.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00631566.
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Clinic, Walter Reed National Military Medical Center, Bethesda, MD, United States of America.
authors.forename: Amy
authors.initials: A
authors.lastname: Weintrob
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America.
authors.forename: Ionut
authors.initials: I
authors.lastname: Bebu
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America.
authors.forename: Brian
authors.initials: B
authors.lastname: Agan
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Clinic, Naval Medical Center San Diego, San Diego, CA, United States of America.
authors.forename: Alona
authors.initials: A
authors.lastname: Diem
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Service, San Antonio Military Medical Center, San Antonio, TX, United States of America.
authors.forename: Erica
authors.initials: E
authors.lastname: Johnson
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Clinic, Naval Medical Center, Portsmouth, VA, United States of America.
authors.forename: Tahaniyat
authors.initials: T
authors.lastname: Lalani
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America.
authors.forename: Xun
authors.initials: X
authors.lastname: Wang
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Clinic, Naval Medical Center San Diego, San Diego, CA, United States of America.
authors.forename: Mary
authors.initials: M
authors.lastname: Bavaro
authors.affiliation: Department of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America.
authors.forename: Michael
authors.initials: M
authors.lastname: Ellis
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Service, San Antonio Military Medical Center, San Antonio, TX, United States of America.
authors.forename: Katrin
authors.initials: K
authors.lastname: Mende
authors.affiliation: Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, United States of America; Infectious Disease Clinic, Naval Medical Center San Diego, San Diego, CA, United States of America.
authors.forename: Nancy
authors.initials: N
authors.lastname: Crum-Cianflone
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000382:microbiology*; D006582:Hexachlorophene / Q000008:administration & dosage; D006801:Humans; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects* / Q000821:virology; D008875:Middle Aged; D016712:Mupirocin / Q000008:administration & dosage; D011446:Prospective Studies; D013203:Staphylococcal Infections / Q000188:drug therapy* / Q000382:microbiology / Q000821:virology
chemical_list: D000900:Anti-Bacterial Agents; D016712:Mupirocin; D006582:Hexachlorophene