Study design (if review, criteria of inclusion for studies)
Non-blinded randomised controlled trial
Participants
45 clinically stable cystic fibrosis patients (44% female, 4-45 years, mean age 11.5 years) with newly positive methicillin resistant Staphylococcus aureus (MRSA) cultures.
Interventions
a non-blinded eradication protocol (Rx) compared with observation (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.
Outcome measures
The primary end point was MRSA culture status at day 28.
Main 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.
Authors' conclusions
This MRSA eradication protocol for newly acquired MRSA demonstrated microbiological efficacy with a large treatment effect.