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

Chang, Anne B., Grimwood, Keith, Robertson, Colin F., Wilson, Andrew C., van Asperen, Peter P., O'Grady, Kerry-Ann F., Sloots, Theo P., Torzillo, Paul J., Bailey, Emily J., Mccallum, Gabrielle B., Masters, Ian B., Byrnes, Catherine .A, Buntain, Helen M., Morris, Peter S., Mackay, Ian M. and Chatfield, Mark D. (2012) Antibiotics for bronchiectasis exacerbations in children: Rationale and study protocol for a randomised placebo-controlled trial. Trials, 13 156: 156-1-156-9.


Author Chang, Anne B.
Grimwood, Keith
Robertson, Colin F.
Wilson, Andrew C.
van Asperen, Peter P.
O'Grady, Kerry-Ann F.
Sloots, Theo P.
Torzillo, Paul J.
Bailey, Emily J.
Mccallum, Gabrielle B.
Masters, Ian B.
Byrnes, Catherine .A
Buntain, Helen M.
Morris, Peter S.
Mackay, Ian M.
Chatfield, Mark D.
Title Antibiotics for bronchiectasis exacerbations in children: Rationale and study protocol for a randomised placebo-controlled trial
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
Publication date 2012-08
Sub-type Article (original research)
DOI 10.1186/1745-6215-13-156
Volume 13
Issue 156
Start page 156-1
End page 156-9
Total pages 9
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2013
Language eng
Formatted 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.
Keyword Bronchiectasis
Respiratory exacerbations
Open Access Mandate Compliance Yes - Open Access (Publisher DOI)
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Published online: 31 August 2012. Article number156

Document type: Journal Article
Sub-type: Article (original research)
Collections: Faculty of Health and Behavioural Sciences -- Publications
Official 2013 Collection
School of Medicine Publications
 
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Citation counts: TR Web of Science Citation Count  Cited 3 times in Thomson Reuters Web of Science Article | Citations
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Created: Mon, 10 Sep 2012, 11:40:47 EST by Roxanne Jemison on behalf of Queensland Children's Medical Research Institute