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ARTICLE JOURNAL CLUB Comparative Efficacy and Safety of 4 Randomized Regimens to Treat Early Pseudomonas aeruginosa Infection in Children With Cystic Fibrosis Miriam M. Treggiari, MD, PhD, MPH; George Retsch-Bogart, MD; Nicole Mayer-Hamblett, PhD; Umer Khan, MS; Michal Kulich, PhD; Richard Kronmal, PhD; Judy Williams, MPH†; Peter Hiatt, MD; Ronald L. Gibson, MD, PhD; Terry Spencer, MD; David Orenstein, MD; Barbara A. Chatfield, MD; Deborah K. Froh, MD; Jane L. Burns, MD; Margaret Rosenfeld, MD, MPH; Bonnie W. Ramsey, MD; for the Early Pseudomonas Infection Control (EPIC) Investigators Objective: To investigate the efficacy and safety of 4 an- nous antibiotics and proportion of P aeruginosa–positive tipseudomonal treatments in children with cystic fibrosis cultures. with recently acquired Pseudomonas aeruginosa infection. Results: The intention-to-treat analysis included 304 par- Design: Randomized controlled trial. ticipants. There was no interaction between treatments. There were no statistically significant differences in ex- Setting: Multicenter trial in the United States. acerbation rates between cycled and culture-based groups (hazard ratio, 0.95; 95% confidence interval [CI], 0.54- Participants: Three hundred four children with cystic 1.66) or ciprofloxacin and placebo (hazard ratio, 1.45; fibrosis aged 1 to 12 years within 6 months of P aerugi- 95% CI, 0.82-2.54). The odds
JAMA Pediatrics – American Medical Association
Published: Sep 1, 2011
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