Comparative efficacy and safety of 4 randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis

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

Research output: Contribution to journalArticle

137 Scopus citations

Abstract

Objective: To investigate the efficacy and safety of 4 antipseudomonal treatments in children with cystic fibrosis with recently acquired Pseudomonas aeruginosa infection. Design: Randomized controlled trial. Setting: Multicenter trial in the United States. Participants: Three hundred four children with cystic fibrosis aged 1 to 12 years within 6 months of P aeruginosa detection. Interventions: Participants 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 Measures: The primary end points were time to pulmonary exacerbation requiring intravenous antibiotics and proportion of P aeruginosa - positive cultures. Results: The 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. Conclusions: No 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 Registration: ClinicalTrials.gov Identifier: NCT00097773.

Original languageEnglish (US)
Pages (from-to)847-856
Number of pages10
JournalArchives of Pediatrics and Adolescent Medicine
Volume165
Issue number9
DOIs
StatePublished - Sep 2011

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    Treggiari, M. M., Retsch-Bogart, G., Mayer-Hamblett, N., Khan, U., Kulich, M., Kronmal, R., Williams, J., Hiatt, P., Gibson, R. L., Spencer, T., Orenstein, D., Chatfield, B. A., Froh, D. K., Burns, J. L., Rosenfeld, M., & Ramsey, B. W. (2011). Comparative efficacy and safety of 4 randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis. Archives of Pediatrics and Adolescent Medicine, 165(9), 847-856. https://doi.org/10.1001/archpediatrics.2011.136