Early use of Antibiotics for at Risk CHildren with InfluEnza (ARCHIE): protocol for a double-blind, randomised, placebo-controlled trial)

Kay Wang, Tricia Carver, Sharon Tonner, Malcolm Semple, Alastair Hay, Michael Moore, Paul Little, Christopher Butler, Andrew Farmer, Rafael Perera, Ly-Mee Yu, Susan Mallett, Jane Wolstenholme, Anthony Harnden

Research output: Contribution to journalArticle (Academic Journal)peer-review

1 Citation (Scopus)
44 Downloads (Pure)

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 ‘at risk’ children.

Methods and analysis 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.


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.
Original languageEnglish
Article numbere021144
Number of pages10
JournalBMJ Open
Volume8
Issue number5
Early online date16 May 2018
DOIs
Publication statusPublished - May 2018

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