About: Amoxicillin–clavulanate versus azithromycin for respiratory exacerbations in children with bronchiectasis (BEST-2): a multicentre, double-blind, non-inferiority, randomised controlled trial

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About: Amoxicillin–clavulanate versus azithromycin for respiratory exacerbations in children with bronchiectasis (BEST-2): a multicentre, double-blind, non-inferiority, randomised controlled trial Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Amoxicillin–clavulanate versus azithromycin for respiratory exacerbations in children with bronchiectasis (BEST-2): a multicentre, double-blind, non-inferiority, randomised controlled trial
Creator	Grimwood, Keith Goyal, Vikas Petsky, Helen Binks, Michael Chang, Anne Mccallum, Gabrielle Morris, Peter Torzillo, Paul Ware, Robert Buntain, Helen Byrnes, Catherine Marchant, Julie Van Asperen, Peter O', Kerry-Ann Phd, Grady
source	Elsevier; Medline; PMC
abstract	BACKGROUND: Although amoxicillin–clavulanate is the recommended first-line empirical oral antibiotic treatment for non-severe exacerbations in children with bronchiectasis, azithromycin is also often prescribed for its convenient once-daily dosing. No randomised controlled trials involving acute exacerbations in children with bronchiectasis have been published to our knowledge. We hypothesised that azithromycin is non-inferior to amoxicillin-clavulanate for resolving exacerbations in children with bronchiectasis. METHODS: We did this parallel-group, double-dummy, double-blind, non-inferiority randomised controlled trial in three Australian and one New Zealand hospital between April, 2012, and August, 2016. We enrolled children aged 1–19 years with radiographically proven bronchiectasis unrelated to cystic fibrosis. At the start of an exacerbation, children were randomly assigned to oral suspensions of either amoxicillin–clavulanate (22·5 mg/kg, twice daily) and placebo or azithromycin (5 mg/kg per day) and placebo for 21 days. We used permuted block randomisation (stratified by age, site, and cause) with concealed allocation. The primary outcome was resolution of exacerbation (defined as a return to baseline) by 21 days in the per-protocol population, with a non-inferiority margin of −20%. We assessed several secondary outcomes including duration of exacerbation, time to next exacerbation, laboratory, respiratory, and quality-of-life measurements, and microbiology. This trial was registered with the Australian/New Zealand Registry (ACTRN12612000010897). FINDINGS: We screened 604 children and enrolled 236. 179 children had an exacerbation and were assigned to treatment: 97 to amoxicillin–clavulanate, 82 to azithromycin). By day 21, 61 (84%) of 73 exacerbations had resolved in the azithromycin group versus 73 (84%) of 87 in the amoxicillin–clavulanate group. The risk difference showed non-inferiority (−0·3%, 95% CI −11·8 to 11·1). Exacerbations were significantly shorter in the amoxicillin–clavulanate group than in the azithromycin group (median 10 days [IQR 6–15] vs 14 days [8–16]; p=0·014). Adverse events were attributed to the trial medication in 17 (21%) of 82 children in the azithromycin group versus 23 (24%) of 97 in the amoxicillin–clavulanate group (relative risk 0·9, 95% CI 0·5 to 1·5). INTERPRETATION: By 21 days of treatment, azithromycin is non-inferior to amoxicillin–clavulanate for resolving exacerbations in children with non-severe bronchiectasis. In some patients, such as those with penicillin hypersensitivity or those likely to have poor adherence, azithromycin provides another option for treating exacerbations, but must be balanced with risk of treatment failure (within a 20% margin), longer exacerbation duration, and the risk of inducing macrolide resistance. FUNDING: Australian National Health and Medical Research Council.
has issue date	2018-09-18(xsd:dateTime)
bibo:doi	10.1016/s0140-6736(18)31723-9
bibo:pmid	30241722
has license	no-cc
sha1sum (hex)	b2b4321e9556f10cf8a4ba5ca7974e65ba4ff401
schema:url	https://doi.org/10.1016/s0140-6736%2818%2931723-9
resource representing a document's title	Amoxicillin–clavulanate versus azithromycin for respiratory exacerbations in children with bronchiectasis (BEST-2): a multicentre, double-blind, non-inferiority, randomised controlled trial
has PubMed Central identifier	PMC7159066
has PubMed identifier	30241722
schema:publication	Lancet
resource representing a document's body	covid:b2b4321e9556f10cf8a4ba5ca7974e65ba4ff401#body_text
is schema:about of	named entity 'BEST' named entity 'bronchiectasis' named entity 'SUPPLEMENT' named entity 'AZITHROMYCIN' named entity 'BRONCHIECTASIS' named entity 'BLIND' named entity 'AUTHORS' named entity 'RESPIRATORY' named entity 'post' named entity 'submission' named entity 'BEST' named entity 'randomised controlled trial' named entity 'bronchiectasis' named entity 'paediatric' named entity 'antibiotics' named entity 'subgroup analysis' named entity 'Chlamydiales' named entity 'forced expiratory volume' named entity 'standard deviation' named entity 'cough' named entity 'antibiotic' named entity 'macrolide antibiotics' named entity 'ENT' named entity 'virus' named entity 'azithromycin' named entity 'cough' named entity 'cough' named entity 'FEV' named entity 'statistical methods' named entity 'subgroup analyses' named entity 'C-reactive protein' named entity 'forced expiratory volume' named entity 'amoxicillin-clavulanate' named entity 'risk difference' named entity 'ITT' named entity 'treatment groups' named entity 'amoxicillin-clavulanate' named entity 'long-term' named entity 'co-trimoxazole' named entity 'subgroup analysis' named entity 'azithromycin' named entity 'virus' named entity 'azithromycin' named entity 'virus' named entity 'randomised controlled trials' named entity 'amoxicillin-clavulanate' named entity 'CRP' named entity 'macrolides' named entity 'risk difference' named entity 'meta-analyses' named entity 'azithromycin' named entity 'amoxicillin-clavulanate' named entity 'FEV' named entity 'amoxicillin-clavulanate' named entity 'quality-of-life' named entity 'bronchiectasis' named entity 'pathogen' named entity 'spirometry' named entity 'CRP' named entity 'inflammatory' named entity 'WBC' named entity 'Exacerbation' named entity 'virus' named entity 'nasopharyngeal' named entity 'nasal swab' named entity 'WBC' named entity 'white blood cell count'

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