Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

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dc.contributor.author Chang, AB en
dc.contributor.author Grimwood, K en
dc.contributor.author Robertson, CF en
dc.contributor.author Wilson, AC en
dc.contributor.author van Asperen, PP en
dc.contributor.author O'Grady, K-AF en
dc.contributor.author Sloots, TP en
dc.contributor.author Torzillo, PJ en
dc.contributor.author Bailey, EJ en
dc.contributor.author McCallum, GB en
dc.contributor.author Masters, IB en
dc.contributor.author Byrnes, Catherine en
dc.contributor.author Chatfield, MD en
dc.contributor.author Buntain, HM en
dc.contributor.author Mackay, IM en
dc.contributor.author Morris, PS en
dc.date.accessioned 2017-08-24T21:53:07Z en
dc.date.available 2012-04-16 en
dc.date.issued 2012-08-31 en
dc.identifier.citation Trials, 13: Article number 156, 31 Aug 2012 en
dc.identifier.uri http://hdl.handle.net/2292/35349 en
dc.description.abstract Background: Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis.Methods: We are conducting a bronchiectasis exacerbation study (BEST), which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland). In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed) to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily) with placebo-azithromycin; azithromycin (5 mg/kg daily) with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported.Discussion: Effective, evidence-based management of exacerbations in people with bronchiectasis is clinically important. Yet, there are few randomised controlled trials (RCTs) in the neglected area of non-cystic fibrosis bronchiectasis. Indeed, no published RCTs addressing the treatment of bronchiectasis exacerbations in children exist. Our multicentre, double-blind RCT is designed to determine if azithromycin and amoxicillin-clavulanic acid, compared with placebo, improve symptom resolution on day 14 in children with acute respiratory exacerbations. Our planned assessment of the predictors of antibiotic response, the role of antibiotic-resistant respiratory pathogens, and whether early treatment with antibiotics affects duration and time to the next exacerbation, are also all novel.Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR) number ACTRN12612000011886. en
dc.description.uri https://www.ncbi.nlm.nih.gov/pubmed/22937736 en
dc.language English en
dc.publisher BioMed Central en
dc.relation.ispartofseries Trials en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. Details obtained from http://sherpa.ac.uk/romeo/issn/1745-6215/ https://www.biomedcentral.com/getpublished/copyright-and-license en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.rights.uri https://creativecommons.org/licenses/by/2.0/ en
dc.title Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial en
dc.type Journal Article en
dc.identifier.doi 10.1186/1745-6215-13-156 en
pubs.volume 13 en
dc.description.version VoR - Version of Record en
dc.rights.holder Copyright: The authors en
dc.identifier.pmid 22937736 en
pubs.author-url https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-156 en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/OpenAccess en
pubs.subtype Article en
pubs.elements-id 364575 en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Paediatrics Child & Youth Hlth en
dc.identifier.eissn 1745-6215 en
pubs.number 156 en
pubs.record-created-at-source-date 2017-08-25 en
pubs.dimensions-id 22937736 en


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