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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., Chatfield, Mark D., Buntain, Helen M., Mackay, Ian M. and Morris, Peter S. (2012). Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial. Trials,13(1):156-164.

Document type: Journal Article
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IRMA ID cmartelxPUB38
NHMRC Grant No. 1019834
1040830
Title Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial
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.
Chatfield, Mark D.
Buntain, Helen M.
Mackay, Ian M.
Morris, Peter S.
Journal Name Trials
Publication Date 2012
Volume Number 13
Issue Number 1
ISSN 1745-6215   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-84865546970
Start Page 156
End Page 164
Total Pages 9
Place of Publication London, U.K
Publisher BioMed Central Ltd.
HERDC Category C1 - Journal Article (DIISR)
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.
Keywords Amoxicillin-clavulanic acid
Azithromycin
Bronchiectasis
Placebo
Pulmonary exacerbations
Randomised controlled trial
DOI http://dx.doi.org/10.1186/1745-6215-13-156   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)


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Created: Tue, 13 Nov 2012, 17:19:35 CST by Teresa Haendel