TY  - JOUR
T1  - COmparative efficacy and safety of 4 randomized regimens to treat early pseudomonas aeruginosa infection in children with cystic fibrosis
AU  - Treggiari MM, Retsch-Bogart G, Mayer-Hamblett N, et al
Y1  - 2011/09/01
N1  - 10.1001/archpediatrics.2011.136
JO  - Archives of Pediatrics & Adolescent Medicine
SP  - 847
EP  - 856
VL  - 165
IS  - 9
N2  - 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.
SN  - 1072-4710
M3  - doi: 10.1001/archpediatrics.2011.136
UR  - http://dx.doi.org/10.1001/archpediatrics.2011.136
ER  -