RT Journal Article
SR Electronic
T1 Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial
JF Thorax
JO Thorax
FD BMJ Publishing Group Ltd and British Thoracic Society
SP 318
OP 326
DO 10.1136/thoraxjnl-2016-208949
VO 72
IS 4
A1 Marianne Sponer Muhlebach
A1 Valeria Beckett
A1 Elena Popowitch
A1 Melissa B Miller
A1 Arthur Baines
A1 Nicole Mayer-Hamblett
A1 Edith T Zemanick
A1 Wynton C Hoover
A1 Jill M VanDalfsen
A1 Preston Campbell
A1 Christopher H Goss
A1 STAR-too study team
YR 2017
UL http://thorax.bmj.com/content/72/4/318.abstract
AB 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 Staphylococcus aureus (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.