1. Oral antibiotics vs placebo for exacerbations of paediatric bronchiectasis
- Author
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André Schultz, Vikas Goyal, I B Masters, Gabrielle B. McCallum, Anita Champion, Paul J. Torzillo, Kerry-Ann F. O'Grady, Catherine Brynes, Heidi C. Smith-Vaughan, Keith Grimwood, Anne B. Chang, Michael J. Binks, Helen M. Buntain, Robert S. Ware, Peter S. Morris, and Mark D. Chatfield
- Subjects
medicine.medical_specialty ,Bronchiectasis ,Exacerbation ,medicine.drug_class ,business.industry ,Antibiotics ,Placebo ,Azithromycin ,medicine.disease ,Confidence interval ,Relative risk ,Statistical significance ,Internal medicine ,medicine ,business ,medicine.drug - Abstract
Background: Bronchiectasis guidelines recommend antibiotics for treating acute respiratory exacerbations, but no RCTs of antibiotics vs placebo exist. Aim: We hypothesized that oral amoxicillin-clavulanate (amox-clav) and azithromycin (azitho) are both superior to placebo for achieving resolution by day-14 when treating non-severe exacerbations in children. Methods: Our multicentre (n=4), double-dummy, double-blind, placebo-controlled trial randomized children aged 1-19 years at exacerbation start to amox-clav (45mg/kg/day) + azithro-placebo; azithro (5mg/kg/day) + amox-clav-placebo; or placebo + placebo for 14-days. The primary outcome was exacerbation resolution by day-14. Secondary outcomes were exacerbation duration, time-to-next exacerbation, quality-of-life, laboratory and FEV1 assessments and nasopharyngeal microbiology. Statistical significance was set at P
- Published
- 2019