• Miriam M Treggiari, George Retsch-Bogart, Nicole Mayer-Hamblett, Umer Khan, Michal Kulich, Richard Kronmal, Judy Williams, Peter Hiatt, Ronald L Gibson, Terry Spencer, David Orenstein, Barbara A Chatfield, Deborah K Froh, Jane L Burns, Margaret Rosenfeld, Bonnie W Ramsey, and Early Pseudomonas Infection Control (EPIC) Investigators.
• Department of Anesthesiology and Pain Medicine, Seattle Children’s Hospital, WA 98104, USA. treggmm@uw.edu
• Arch Pediatr Adolesc Med. 2011 Sep 1;165(9):847-56.

ObjectiveTo investigate the efficacy and safety of 4 antipseudomonal treatments in children with cystic fibrosis with recently acquired Pseudomonas aeruginosa infection.DesignRandomized controlled trial.SettingMulticenter trial in the United States.ParticipantsThree hundred four children with cystic fibrosis aged 1 to 12 years within 6 months of P aeruginosa detection.InterventionsParticipants were randomized to 1 of 4 antibiotic regimens for 18 months (six 12-week quarters) between December 2004 and June 2009. Participants randomized to cycled therapy received tobramycin inhalation solution (300 mg twice a day) for 28 days, with oral ciprofloxacin (15-20 mg/kg twice a day) or oral placebo for 14 days every quarter, while participants randomized to culture-based therapy received the same treatments only during quarters with positive P aeruginosa cultures.Main Outcome MeasuresThe primary end points were time to pulmonary exacerbation requiring intravenous antibiotics and proportion of P aeruginosa -positive cultures.ResultsThe intention-to-treat analysis included 304 participants. There was no interaction between treatments. There were no statistically significant differences in exacerbation rates between cycled and culture-based groups (hazard ratio, 0.95; 95% confidence interval [CI], 0.54-1.66) or ciprofloxacin and placebo (hazard ratio, 1.45; 95% CI, 0.82-2.54). The odds ratios of P aeruginosa- positive culture comparing the cycled vs culture-based group were 0.78 (95% CI, 0.49-1.23) and 1.10 (95% CI, 0.71-1.71) comparing ciprofloxacin vs placebo. Adverse events were similar across groups.ConclusionsNo difference in the rate of exacerbation or prevalence of P aeruginosa positivity was detected between cycled and culture-based therapies. Adding ciprofloxacin produced no benefits.Trial RegistrationClinicalTrials.gov Identifier: NCT00097773.

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