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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 resistant Staphylococcusaureus (MRSA) cultures.Design
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.Trial registration number
NCT01349192.
SUBMITTER: Muhlebach MS
PROVIDER: S-EPMC5489741 | biostudies-literature | 2017 Apr
REPOSITORIES: biostudies-literature
Muhlebach Marianne Sponer MS Beckett Valeria V Popowitch Elena E Miller Melissa B MB Baines Arthur A Mayer-Hamblett Nicole N Zemanick Edith T ET Hoover Wynton C WC VanDalfsen Jill M JM Campbell Preston P Goss Christopher H CH
Thorax 20161115 4
<h4>Objective</h4>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 resistant <i>Staphylococcus</i><i>aureus</i> (MRSA) cultures.<h4>Design</h4>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 wit ...[more]