Pseudomonas aeruginosa culture positivity was significantly reduced following ivacaftor treatment. Efficacious CFTR modulation may contribute to lower frequency of culture positivity for P. aeruginosa and other respiratory pathogens, particularly in patients with less established disease.
Objective
To evaluate microbiologic effectiveness, i.e. culture negativity of a non-blinded eradication protocol (Rx) compared to observation (Obs) in clinically stable cystic fibrosis participants with newly positive MRSA cultures.
Design
This non-blinded trial randomized participants ages 4-45 years with first or early (≤2 positive cultures within 3 years) MRSA positive culture without MRSA-active antibiotics within 4 week 1:1 to Rx or Obs. The Rx protocol was: oral trimethoprim-sulfamethoxazole or if sulfa-allergic, minocycline plus oral rifampin; chlorhexidine mouthwash for two weeks; nasal mupirocin and chlorhexidine body wipes for five days, and environmental decontamination for 21 days. The primary endpoint was MRSA culture status at day 28.
Results
Between April 1, 2011 to September 2014, forty-five participants (44% female, mean age 11.5 years) were randomized (24 Rx, 21 Obs). At Day 28, 82% (n=18/22) of participants in the Rx-arm compared to 26% (n=5/19) in Obs-arm were MRSA negative. Adjusted for interim monitoring, this difference was 52% (95% CI: 23%, 80%; p<0.001). Limiting analyses to participants who were MRSA positive at the screening visit, 67% (8/12) in the Rx and 13% (2/15) in the Obs-arm were MRSA negative at Day 28, adjusted difference: 49% (95% CI: 22%,71%, p<0.001). Fifty-four percent in the Rx compared to 10% participants in the Obs-arm remained MRSA negative through Day 84. Mild gastrointestinal side effects were higher in the Rx-arm.
Conculsions
This MRSA eradication protocol for newly acquired MRSA demonstrated microbiologic efficacy with a large treatment effect.
Trial Registration
www.clinicaltrials.gov NCT01349192
Objective-To compare the effectiveness of three methods of taking an antenatal history on the quality ofobstetric care.Design-Randomised controlled trial. Setting-Antenatal clinic of St James's University Hospital, Leeds.Subjects-2424 women attending the hospital for the first (booking) visit.Interventions-Histories were taken by midwives using an unstructured paper questionnaire, a structured paper questionnaire (incorporating a checklist), or an interactive computerised questionnaire (incorporating 101 clinical reminders).Main outcome measures-The number of clinical responses to factors arising from the antenatal booking history according to method of taking the history. Actions were categorised as medical and surgical, obstetric, personal, current symptoms and treatment, related to maternal age, and related to two common actions (cervical smear testing and dental hygiene) and were weighted for clinical importance by 10 obstetricians.
Patients with non-G551D gating mutations experienced improved lung function, nutritional status, and quality of life. This study supports ongoing use of ivacaftor for patients with these mutations.
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