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Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial

Chang, Anne B., Grimwood, Keith, Wilson, Andrew C., van Asperen, Peter, Byrnes, Catherine A., O'Grady, Kerry-Ann F., Sloots, Theo P., Robertson, Colin F., Torzillo, Paul J., McCallum, Gabrielle B., Masters, Ian B., Buntain, Helen M., Mackay, Ian M., Ungerer, Jacobus, Tuppin, Joanne and Morris, Peter S. (2013). Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial. Trials,14(53):1-10.

Document type: Journal Article
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ARC Grant No. 545216
IRMA ID MENbsnellxPUB60
NHMRC Grant No. 1019834
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Title Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial
Author Chang, Anne B.
Grimwood, Keith
Wilson, Andrew C.
van Asperen, Peter
Byrnes, Catherine A.
O'Grady, Kerry-Ann F.
Sloots, Theo P.
Robertson, Colin F.
Torzillo, Paul J.
McCallum, Gabrielle B.
Masters, Ian B.
Buntain, Helen M.
Mackay, Ian M.
Ungerer, Jacobus
Tuppin, Joanne
Morris, Peter S.
Journal Name Trials
Publication Date 2013
Volume Number 14
Issue Number 53
eISSN 1745-6215
Scopus ID 2-s2.0-84873972652
Start Page 1
End Page 10
Total Pages 10
Place of Publication United Kingdom
Publisher BioMed Central Ltd.
HERDC Category C2 - Journal Article - Other contributions to refereed journal (internal)
Abstract Background
Bronchiectasis unrelated to cystic fibrosis (CF) is being increasingly recognized in children and adults globally, both in resource-poor and in affluent countries. However, high-quality evidence to inform management is scarce. Oral amoxycillin-clavulanate is often the first antibiotic chosen for non-severe respiratory exacerbations, because of the antibiotic-susceptibility patterns detected in the respiratory pathogens commonly associated with bronchiectasis. Azithromycin has a prolonged half-life, and with its unique anti-bacterial, immunomodulatory, and anti-inflammatory properties, presents an attractive alternative. Our proposed study will test the hypothesis that oral azithromycin is non-inferior (within a 20% margin) to amoxycillin-clavulanate at achieving resolution of non-severe respiratory exacerbations by day 21 of treatment in children with non-CF bronchiectasis

Methods
This will be a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial involving six Australian and New Zealand centers. In total, 170 eligible children will be stratified by site and bronchiectasis etiology, and randomized (allocation concealed) to receive: 1) azithromycin (5 mg/kg daily) with placebo amoxycillin-clavulanate or 2) amoxycillin-clavulanate (22.5 mg/kg twice daily) with placebo azithromycin for 21 days as treatment for non-severe respiratory exacerbations. Clinical data and a parent-proxy cough-specific quality of life (PC-QOL) score will be obtained at baseline, at the start and resolution of exacerbations, and on day 21. In most children, blood and deep-nasal swabs will also be collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 21. The main secondary outcome is the PC-QOL score. Other outcomes are: time to next exacerbation; requirement for hospitalization; duration of exacerbation, and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood inflammatory markers will be reported where available.

Discussion
Currently, there are no published randomized controlled trials (RCT) to underpin effective, evidence-based management of acute respiratory exacerbations in children with non-CF bronchiectasis. To help address this information gap, we are conducting two RCTs. The first ( bronchiectasis exacerbation study; BEST-1) evaluates the efficacy of azithromycin and amoxycillin-clavulanate compared with placebo, and the second RCT (BEST-2), described here, is designed to determine if azithromycin is non-inferior to amoxycillin-clavulanate in achieving symptom resolution by day 21 of treatment in children with acute respiratory exacerbations
Keywords Amoxycillin-clavulanate
Azithoromycin
Bronchiectasis
Placebo
Pulmonary exacerbations
Randomized controlled trial
DOI http://dx.doi.org/10.1186/1745-6215-14-53   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 2.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 2.0 License
URL https://creativecommons.org/licenses/by/2.0/au/legalcode


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