title: Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial.
abstract: OBJECTIVE
  To evaluate microbiological effectiveness, that is, culture negativity of a non-blinded eradication protocol (Rx) compared with observation (Obs) in clinically stable cystic fibrosis participants with newly positive methicillin resistantStaphylococcusaureus(MRSA) cultures.
  
  
  METHODS
  This non-blinded trial randomised participants ages 4-45 years with first or early (≤2 positive cultures within 3 years) MRSA-positive culture without MRSA-active antibiotics within 4 weeks 1:1 to Rx or Obs. The Rx protocol was: oral trimethoprim-sulfamethoxazole or if sulfa-allergic, minocycline plus oral rifampin; chlorhexidine mouthwash for 2 weeks; nasal mupirocin and chlorhexidine body wipes for 5 days and environmental decontamination for 21 days. The primary end point was MRSA culture status at day 28.
  
  
  RESULTS
  Between 1 April 2011 to September 2014, 45 participants (44% female, mean age 11.5 years) were randomised (24 Rx, 21 Obs). At day 28, 82% (n=18/22) of participants in the Rx arm compared with 26% (n=5/19) in the Obs arm were MRSA-negative. Adjusted for interim monitoring, this difference was 52% (95% CI 23% to 80%, p<0.001). Limiting analyses to participants who were MRSA-positive at the screening visit, 67% (8/12) in the Rx arm and 13% (2/15) in the Obs arm were MRSA-negative at day 28, adjusted difference: 49% (95% CI 22% to 71%, p<0.001). Fifty-four per cent in the Rx arm compared with 10% participants in the Obs arm remained MRSA-negative through day 84. Mild gastrointestinal side effects were higher in the Rx arm.
  
  
  CONCLUSIONS
  This MRSA eradication protocol for newly acquired MRSA demonstrated microbiological efficacy with a large treatment effect.
  
  
  BACKGROUND
  NCT01349192.
authors.affiliation: Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Marianne Sponer
authors.initials: MS
authors.lastname: Muhlebach
authors.affiliation: Seattle Children's Research Institute, Seattle, Washington, USA.
authors.forename: Valeria
authors.initials: V
authors.lastname: Beckett
authors.affiliation: Department of Microbiology, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Elena
authors.initials: E
authors.lastname: Popowitch
authors.affiliation: Department of Microbiology, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Melissa B
authors.initials: MB
authors.lastname: Miller
authors.affiliation: Seattle Children's Research Institute, Seattle, Washington, USA.
authors.forename: Arthur
authors.initials: A
authors.lastname: Baines
authors.affiliation: Seattle Children's Research Institute, Seattle, Washington, USA.|Department of Pediatrics, University of Washington, Seattle, Washington, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Mayer-Hamblett
authors.affiliation: Department of Pediatrics, University of Colorado School of Medicine, Denver, Colorado, USA.
authors.forename: Edith T
authors.initials: ET
authors.lastname: Zemanick
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: Wynton C
authors.initials: WC
authors.lastname: Hoover
authors.affiliation: Seattle Children's Research Institute, Seattle, Washington, USA.
authors.forename: Jill M
authors.initials: JM
authors.lastname: VanDalfsen
authors.affiliation: Cystic Fibrosis Foundation, Bethesda, Maryland, USA.
authors.forename: Preston
authors.initials: P
authors.lastname: Campbell
authors.affiliation: Seattle Children's Research Institute, Seattle, Washington, USA.|Department of Pediatrics, University of Washington, Seattle, Washington, USA.|Department of Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Goss
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002710:Chlorhexidine / Q000627:therapeutic use; D003550:Cystic Fibrosis / Q000382:microbiology*; D005260:Female; D006801:Humans; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus / Q000302:isolation & purification*; D008875:Middle Aged; D008911:Minocycline / Q000627:therapeutic use; D013203:Staphylococcal Infections / Q000188:drug therapy* / Q000382:microbiology*; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D008911:Minocycline; D002710:Chlorhexidine
keywords: Bacterial Infection; Cystic Fibrosis; Infection Control