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

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

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Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial
Creator	Grimwood, Keith Sloots, Theo Robertson, Colin Wilson, Andrew Chang, Anne Mackay, Ian Mccallum, Gabrielle Morris, Peter Torzillo, Paul Buntain, Helen Byrnes, Catherine O'grady, Kerry-Ann Van Asperen, Peter Masters, Ian Tuppin, Joanne Ungerer, Jacobus
Source	Medline; PMC
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. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR) number http://ACTRN12612000010897. http://www.anzctr.org.au/trial_view.aspx?id=347879
has issue date	2013-02-20(xsd:dateTime)
bibo:doi	10.1186/1745-6215-14-53
bibo:pmid	23421781
has license	cc-by
sha1sum (hex)	1aeb7a9cfcab3236c6b4168ccac7479a73e5f38b
schema:url	https://doi.org/10.1186/1745-6215-14-53
resource representing a document's title	Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial
has PubMed Central identifier	PMC3586343
has PubMed identifier	23421781
schema:publication	Trials
resource representing a document's body	covid:1aeb7a9cfcab3236c6b4168ccac7479a73e5f38b#body_text
is schema:about of	named entity 'azithromycin' named entity 'study' named entity 'hypothesis' named entity 'respiratory' named entity 'cystic fibrosis' named entity 'anti-bacterial' named entity 'cystic fibrosis' named entity 'bronchiectasis' named entity 'pathogens' named entity '20%' named entity 'Bronchiectasis' named entity 'azithromycin' named entity 'amoxycillin' named entity 'randomized controlled trial' named entity 'Bronchiectasis' named entity 'azithromycin' named entity 'safety profile' named entity 'placebo' named entity 'cough' named entity 'Solna' named entity '0.9' named entity 'bronchiectasis' named entity 'amoxicillin-clavulanate' named entity 'bronchiectasis' named entity 'viruses' named entity 'clavulanate' named entity 'glycerol' named entity 'penicillin' named entity 'amoxycillin' named entity 'SAA' named entity 'morbidity' named entity 'genotypes' named entity 'first-line therapy' named entity 'endobronchial' named entity 'enzyme immunoassay' named entity 'QOL' named entity 'bronchiectasis' named entity 'Mann-Whitney' named entity 'morbidity' named entity 'Streptococcus pneumoniae' named entity 'lung function' named entity 'azithromycin' named entity 'Nucleic acids' named entity 'H. influenzae' named entity 'bronchiectasis' named entity 'Depression' named entity 'chronic cough' named entity 'IBM' named entity 'azithromycin' named entity 'ampicillin' named entity 'pharmacist' named entity 'viruses' named entity 'cough' named entity 'developing countries' named entity 'bronchiectasis' named entity 'azithromycin' named entity 'S. pneumoniae' named entity 'Brisbane' named entity 'resistant bacteria' named entity 'placebo' named entity 'placebo' named entity 'placebo' named entity 'placebos' named entity 'cough' named entity 'azithromycin' named entity 'Serum'

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