Please use this identifier to cite or link to this item: https://hdl.handle.net/10070/301782
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dc.contributor.authorValery, Patricia C-
dc.contributor.authorMorris, Peter S-
dc.contributor.authorByrnes, Catherine A-
dc.contributor.authorGrimwood, Keith-
dc.contributor.authorTorzillo, Paul J-
dc.contributor.authorBauert, Paul A-
dc.contributor.authorMasters, I Brent-
dc.contributor.authorDiaz, Abbey-
dc.contributor.authorMcCallum, Gabrielle B-
dc.contributor.authorMobberley, Charmaine-
dc.contributor.authorTjhung, Irene-
dc.contributor.authorHare, Kim M-
dc.contributor.authorWare, Robert S-
dc.contributor.authorChang, Anne B-
dc.date2013-
dc.date.accessioned2018-05-15T23:01:22Z-
dc.date.accessioned2018-10-04T22:07:45Z-
dc.date.available2018-05-15T23:01:22Z-
dc.date.available2018-10-04T22:07:45Z-
dc.date.issued2013-10-
dc.identifier.citationThe Lancet. Respiratory medicine 2013-10; 1(8): 610-620-
dc.identifier.urihttps://hdl.handle.net/10070/301782-
dc.description.abstractIndigenous children in high-income countries have a heavy burden of bronchiectasis unrelated to cystic fibrosis. We aimed to establish whether long-term azithromycin reduced pulmonary exacerbations in Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease. Between Nov 12, 2008, and Dec 23, 2010, we enrolled Indigenous Australian, Maori, and Pacific Island children aged 1-8 years with either bronchiectasis or chronic suppurative lung disease into a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial. Eligible children had had at least one pulmonary exacerbation in the previous 12 months. Children were randomised (1:1 ratio, by computer-generated sequence with permuted block design, stratified by study site and exacerbation frequency [1-2 vs ≥3 episodes in the preceding 12 months]) to receive either azithromycin (30 mg/kg) or placebo once a week for up to 24 months. Allocation concealment was achieved by double-sealed, opaque envelopes; participants, caregivers, and study personnel were masked to assignment until after data analysis. The primary outcome was exacerbation (respiratory episodes treated with antibiotics) rate. Analysis of the primary endpoint was by intention to treat. At enrolment and at their final clinic visits, children had deep nasal swabs collected, which we analysed for antibiotic-resistant bacteria. This study is registered with the Australian New Zealand Clinical Trials Registry; ACTRN12610000383066. 45 children were assigned to azithromycin and 44 to placebo. The study was stopped early for feasibility reasons on Dec 31, 2011, thus children received the intervention for 12-24 months. The mean treatment duration was 20·7 months (SD 5·7), with a total of 902 child-months in the azithromycin group and 875 child-months in the placebo group. Compared with the placebo group, children receiving azithromycin had significantly lower exacerbation rates (incidence rate ratio 0·50; 95% CI 0·35-0·71; p<0·0001). However, children in the azithromycin group developed significantly higher carriage of azithromycin-resistant bacteria (19 of 41, 46%) than those receiving placebo (four of 37, 11%; p=0·002). The most common adverse events were non-pulmonary infections (71 of 112 events in the azithromycin group vs 132 of 209 events in the placebo group) and bronchiectasis-related events (episodes or investigations; 22 of 112 events in the azithromycin group vs 48 of 209 events in the placebo group); however, study drugs were well tolerated with no serious adverse events being attributed to the intervention. Once-weekly azithromycin for up to 24 months decreased pulmonary exacerbations in Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease. However, this strategy was also accompanied by increased carriage of azithromycin-resistant bacteria, the clinical consequences of which are uncertain, and will need careful monitoring and further study. National Health and Medical Research Council (Australia) and Health Research Council (New Zealand).-
dc.language.isoeng-
dc.titleLong-term azithromycin for Indigenous children with non-cystic-fibrosis bronchiectasis or chronic suppurative lung disease (Bronchiectasis Intervention Study): a multicentre, double-blind, randomised controlled trial.-
dc.typeJournal Article-
dc.typeMulticenter Study-
dc.typeRandomized Controlled Trial-
dc.typeResearch Support, Non-U.S. Gov't-
dc.relation.incollectionDept of Health Digital Library
dc.relation.incommunityE-Books
dc.view.styleebooks
dc.subject.meshAnti-Bacterial Agents-
dc.subject.meshAustralia-
dc.subject.meshAzithromycin-
dc.subject.meshBronchiectasis-
dc.subject.meshCarrier State-
dc.subject.meshChild-
dc.subject.meshChild, Preschool-
dc.subject.meshChronic Disease-
dc.subject.meshDisease Progression-
dc.subject.meshDouble-Blind Method-
dc.subject.meshDrug Resistance, Bacterial-
dc.subject.meshEarly Termination of Clinical Trials-
dc.subject.meshEpisode of Care-
dc.subject.meshFemale-
dc.subject.meshHaemophilus influenzae-
dc.subject.meshHumans-
dc.subject.meshInfant-
dc.subject.meshIntention to Treat Analysis-
dc.subject.meshLength of Stay-
dc.subject.meshLung Diseases-
dc.subject.meshMale-
dc.subject.meshMicrobial Sensitivity Tests-
dc.subject.meshMoraxella (Branhamella) catarrhalis-
dc.subject.meshNose-
dc.subject.meshSeverity of Illness Index-
dc.subject.meshStaphylococcus aureus-
dc.subject.meshStreptococcus pneumoniae-
dc.subject.meshSuppuration-
dc.subject.meshTime Factors-
dc.subject.meshOceanic Ancestry Group-
dc.identifier.journaltitleThe Lancet. Respiratory medicine-
dc.identifier.doi10.1016/S2213-2600(13)70185-1-
dc.identifier.pubmedidhttps://ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/24461664-
dc.identifier.affiliationMenzies School of Health Research, Charles Darwin University, Darwin, NT, Australia. Electronic address: patricia.valery@menzies.edu.au..-
dc.identifier.affiliationMenzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Department of Paediatrics, Royal Darwin Hospital, Darwin, NT, Australia..-
dc.identifier.affiliationDepartment of Paediatrics, University of Auckland, Auckland, New Zealand; Paediatric Respiratory Medicine, Starship Children's Health, Auckland, New Zealand..-
dc.identifier.affiliationQueensland Children's Medical Research Institute, The University of Queensland, Brisbane, QLD, Australia; Queensland Paediatric Infectious Diseases Laboratory, Royal Children's Hospital, Brisbane, QLD, Australia..-
dc.identifier.affiliationUniversity of Sydney, Sydney, NSW, Australia; Royal Prince Alfred Hospital, Sydney, NSW, Australia..-
dc.identifier.affiliationDepartment of Paediatrics, Royal Darwin Hospital, Darwin, NT, Australia..-
dc.identifier.affiliationQueensland Children's Medical Research Institute, The University of Queensland, Brisbane, QLD, Australia; Queensland Children's Respiratory Centre, Royal Children's Hospital, Brisbane, QLD, Australia..-
dc.identifier.affiliationMenzies School of Health Research, Charles Darwin University, Darwin, NT, Australia..-
dc.identifier.affiliationMenzies School of Health Research, Charles Darwin University, Darwin, NT, Australia..-
dc.identifier.affiliationDepartment of Paediatrics, University of Auckland, Auckland, New Zealand..-
dc.identifier.affiliationTorres Strait-Northern Peninsula Hospital and Health Service, Thursday Island, QLD, Australia..-
dc.identifier.affiliationMenzies School of Health Research, Charles Darwin University, Darwin, NT, Australia..-
dc.identifier.affiliationQueensland Children's Medical Research Institute, The University of Queensland, Brisbane, QLD, Australia; School of Population Health, The University of Queensland, Brisbane, QLD, Australia..-
dc.identifier.affiliationMenzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Queensland Children's Respiratory Centre, Royal Children's Hospital, Brisbane, QLD, Australia; Queensland Children's Medical Research Institute, Queensland University of Technology, Brisbane, QLD, Australia..-
dc.identifier.pubmedurihttps://ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/24461664-
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