Journal article
Early use of antibiotics for at risk children with influenza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial
- Abstract:
- 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 'at risk' children.The ARCHIE trial is a double-blind, parallel, randomised, placebo-controlled trial. 'At risk' children aged 6 months to 12 years inclusive who present within the first 5 days 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.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.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.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 χ2/Fisher's exact test and log-binomial regression.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 (www.archiestudy.com) and links with relevant charities.ISRCTN 70714783; Pre-results. EudraCT 2013-002822-21; Pre-results.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 282.7KB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2017-021144
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 8
- Issue:
- 5
- Article number:
- e021144
- Publication date:
- 2018-05-16
- Acceptance date:
- 2018-04-05
- DOI:
- EISSN:
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2044-6055
- Pmid:
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29769256
- Language:
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English
- Keywords:
- Pubs id:
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pubs:848166
- UUID:
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uuid:f1a98b0f-a95a-480e-aac8-4befefaf09eb
- Local pid:
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pubs:848166
- Source identifiers:
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848166
- Deposit date:
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2018-06-11
Terms of use
- Copyright holder:
- Wang et al
- Copyright date:
- 2018
- Notes:
-
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited.
- Licence:
- CC Attribution (CC BY)
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