{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T12:26:03Z","timestamp":1765887963483,"version":"3.48.0"},"reference-count":36,"publisher":"BMJ","issue":"5","funder":[{"DOI":"10.13039\/501100007602","name":"Programme Grants for Applied Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007602","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,4,5]]},"published-print":{"date-parts":[[2018,5]]},"abstract":"\n Introduction<\/jats:title>\n Influenza and influenza-like illness (ILI) create considerable burden on healthcare resources each winter. Children with pre-existing conditions such as asthma, diabetes mellitus and cerebral palsy are among those at greatest risk of clinical deterioration from influenza\/ILI. The Antibiotics for at Risk CHildren with InfluEnza (ARCHIE) trial aims to determine whether early oral treatment with the antibiotic co-amoxiclav reduces the likelihood of reconsultation due to clinical deterioration in these \u2018at risk\u2019 children.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n The ARCHIE trial is a double-blind, parallel, randomised, placebo-controlled trial. \u2018At risk\u2019 children aged 6 months to 12 years inclusive who present within the first 5\u2009days of an ILI episode will be randomised to receive a 5-day course of oral co-amoxiclav 400\/57 twice daily or placebo. Randomisation will use a non-deterministic minimisation algorithm to balance age and seasonal influenza vaccination status.<\/jats:p>\n To detect respiratory virus infections, a nasal swab will be obtained from each participant before commencing study medication. To identify carriage of potential bacterial respiratory pathogens, we will also obtain a throat swab where possible.<\/jats:p>\n The primary outcome is reconsultation in any healthcare setting due to clinical deterioration within 28 days of randomisation. We will analyse this outcome using log-binomial regression model adjusted for region, age and seasonal influenza vaccination status.<\/jats:p>\n \n Secondary outcomes include duration of fever, duration of symptoms and adverse events. Continuous outcomes will be compared using regression analysis (or equivalent non-parametric method for non-normal data) adjusting for minimisation variables. Binary outcomes will be compared using \u03c7\n 2<\/jats:sup>\n \/Fisher\u2019s exact test and log-binomial regression.\n <\/jats:p>\n <\/jats:sec>\n \n Ethics<\/jats:title>\n \n The ARCHIE trial has been reviewed and approved by the North West-Liverpool East Research Ethics Committee, Health Research Authority and Medicines and Healthcare Products Regulatory Agency. Our findings will be published in peer-reviewed journals and disseminated via our study website (\n www.archiestudy.com<\/jats:ext-link>\n ) and links with relevant charities.\n <\/jats:p>\n <\/jats:sec>\n \n Trial registration numbers<\/jats:title>\n \n ISRCTN70714783<\/jats:ext-link>\n ; Pre-results.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-021144","type":"journal-article","created":{"date-parts":[[2021,8,20]],"date-time":"2021-08-20T11:50:33Z","timestamp":1629460233000},"page":"e021144","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Early use of Antibiotics for at Risk CHildren with InfluEnza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"isrctn70714783","registry":"10.18810\/isrctn","type":"preResults"}],"author":[{"given":"Kay","family":"Wang","sequence":"first","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tricia","family":"Carver","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon","family":"Tonner","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malcolm G","family":"Semple","sequence":"additional","affiliation":[{"name":"Women\u2019s and Children\u2019s Health, Institute of Translational Medicine, University of Liverpool, Alder Hey Children\u2019s Hospital, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alastair D","family":"Hay","sequence":"additional","affiliation":[{"name":"Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Moore","sequence":"additional","affiliation":[{"name":"Academic Unit, Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Little","sequence":"additional","affiliation":[{"name":"Academic Unit, Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Butler","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Farmer","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael","family":"Perera","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0331-7364","authenticated-orcid":false,"given":"Ly-Mee","family":"Yu","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Mallett","sequence":"additional","affiliation":[{"name":"Institute of Applied Health Research, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Wolstenholme","sequence":"additional","affiliation":[{"name":"Health Economics Research Centre, Nuffield Department of Population Health, Oxford University, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony","family":"Harnden","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2018,5,16]]},"reference":[{"key":"2025121604215622000_8.5.e021144.1","unstructured":"Department of Health - Immunisation against infectious disease. 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