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Early use of antibiotics for at risk children with influEnza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial

Early use of antibiotics for at risk children with influEnza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial
Early use of antibiotics for at risk children with influEnza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial

Introduction 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 â € at risk' children. Methods and analysis The ARCHIE trial is a double-blind, parallel, randomised, placebo-controlled trial. â € 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 I ‡ 2 /Fisher's exact test and log-binomial regression. Ethics 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. Trial registration numbers ISRCTN 70714783; Pre-results. EudraCT 2013-002822-21; Pre-results.

clinical trials, respiratory infections
2044-6055
1-10
Wang, Kay
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Carver, Tricia
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Tonner, Sharon
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Semple, Malcolm G.
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Hay, Alastair D.
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Moore, Michael
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Little, Paul
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Butler, Christopher
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Farmer, Andrew
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Perera, Rafael
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Yu, Ly Mee
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Mallett, Susan
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Wolstenholme, Jane
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Harnden, Anthony
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Wang, Kay
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Carver, Tricia
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Tonner, Sharon
f9925edf-9219-4e54-89db-cbc84c30d069
Semple, Malcolm G.
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Hay, Alastair D.
bfae9e44-ae9b-473c-923f-1dea50747023
Moore, Michael
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Little, Paul
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Butler, Christopher
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Farmer, Andrew
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Perera, Rafael
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Yu, Ly Mee
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Mallett, Susan
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Wolstenholme, Jane
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Harnden, Anthony
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Wang, Kay, Carver, Tricia, Tonner, Sharon, Semple, Malcolm G., Hay, Alastair D., Moore, Michael, Little, Paul, Butler, Christopher, Farmer, Andrew, Perera, Rafael, Yu, Ly Mee, Mallett, Susan, Wolstenholme, Jane and Harnden, Anthony (2018) Early use of antibiotics for at risk children with influEnza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial. BMJ Open, 8 (5), 1-10, [e021144]. (doi:10.1136/bmjopen-2017-021144).

Record type: Article

Abstract

Introduction 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 â € at risk' children. Methods and analysis The ARCHIE trial is a double-blind, parallel, randomised, placebo-controlled trial. â € 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 I ‡ 2 /Fisher's exact test and log-binomial regression. Ethics 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. Trial registration numbers ISRCTN 70714783; Pre-results. EudraCT 2013-002822-21; Pre-results.

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Accepted/In Press date: 5 April 2018
Published date: 1 May 2018
Keywords: clinical trials, respiratory infections

Identifiers

Local EPrints ID: 423644
URI: http://eprints.soton.ac.uk/id/eprint/423644
ISSN: 2044-6055
PURE UUID: a9f5b47b-3ce2-4807-b380-0a4f34c23b25
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 27 Sep 2018 16:30
Last modified: 07 Oct 2020 01:51

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