Journal Article

Microbiological efficacy of early MRSA treatment in cystic fibrosis in a randomised controlled trial

Hoover, Wynton C, Popowitch, Elena, Beckett, Valeria, VanDalfsen, Jill M, Campbell, Preston, Goss, Christopher H, Baines, Arthur, Muhlebach, Marianne Sponer, Miller, Melissa B, Mayer-Hamblett, Nicole, Zemanick, Edith T

2017

Overview

ObjectiveTo 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.DesignThis 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.ResultsBetween 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.ConclusionsThis MRSA eradication protocol for newly acquired MRSA demonstrated microbiological efficacy with a large treatment effect.Trial registration numberNCT01349192.

• Publisher: BMJ Publishing Group LTD
• Subject: Adolescent / Adult / Anti-Bacterial Agents - therapeutic use / Anti-Infective Agents, Local - therapeutic use / Antibiotics / Child / Child, Preschool / Chlorhexidine - therapeutic use / Contraindications / Cystic fibrosis / Cystic Fibrosis - microbiology / Female / Humans / Male / Methicillin-Resistant Staphylococcus aureus - isolation & purification / Middle Aged / Minocycline - therapeutic use / Spirometry / Staphylococcal Infections - drug therapy / Staphylococcal Infections - microbiology / Staphylococcus aureus / Staphylococcus infections / Treatment Outcome / Trimethoprim, Sulfamethoxazole Drug Combination - therapeutic use