Marc de Moya, Jason S Haukoos, Kamal M F Itani
Practical Guide to Education Program Evaluation Research
JAMA surgery
bronchiectasis guidelines recommend antibiotics treatment acute respiratory exacerbations randomised placebocontrolled trials children lacking hypothesised oral amoxicillinclavulanate azithromycin would superior placebo achieving symptom resolution nonsevere exacerbations children day 14 treatment multicentre threearm parallel doubledummy doubleblind randomised placebocontrolled trial four paediatric centres australia new zealand enrolled children aged 118 years ctconfirmed bronchiectasis unrelated cystic fibrosis care respiratory physician least two respiratory exacerbations 18 months study entry participants allocated 111 exacerbation onset receive oral suspensions amoxicillinclavulanate 45 mgkg per day plus placebo azithromycin azithromycin 5 mgkg per day plus placebo amoxicillinclavulanate placebos 14 days independent statistician prepared computergenerated permutedblock size 28 randomisation sequence stratified centre age cause participants caregivers study coordinators investigators masked treatment assignment data analysis completed primary outcome proportion children exacerbation resolution day 14 intentiontotreat population treatment groups compared using generalised linear models statistical significance set p00245 account multiple comparisons trial registered australian new zealand clinical trials registry actrn12612000011886 completed april 17 2012 march 1 2017 604 children screened 252 enrolled july 31 2012 june 26 2017 197 children allocated start exacerbation 63 amoxicillinclavulanate group 67 azithromycin group 67 placebo group respiratory viruses identified 82 53 154 children available nasal swabs day 1 treatment primary outcome data available 196 99 children one child missing data placebo group recorded nonresolved according criteria defined priori day 14 exacerbations resolved 41 65 children amoxicillinclavulanate group 41 61 azithromycin group 29 43 placebo group compared placebo relative risk resolution day 14 150 95 ci 108209 p0015 numberneededtotreat nnt 5 95 ci 320 amoxicillinclavulanate group 141 101197 p0042 nnt 6 379 azithromycin group adverse events recorded 19 30 children amoxicillinclavulanate group 20 30 azithromycin group 14 21 placebo group events severe lifethreatening amoxicillinclavulanate treatment beneficial terms resolution nonsevere exacerbations bronchiectasis children remain firstline oral antibiotic setting national health medical research council australia cure kids new zealand