Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia: A protocol for a randomIsed controlled Trial (CAP-IT)

Mark D. Lyttle*, Julia A. Bielicki, Sam Barratt, David Dunn, Adam Finn, Lynda Harper, Pauline Jackson, Colin V.E. Powell, Damian Roland, Wolfgang Stohr, Kate Sturgeon, Mandy Wan, Paul Little, Saul N. Faust, Julie Robotham, Alastair D. Hay, Diana M. Gibb, Mike Sharland

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

Introduction Community-acquired pneumonia (CAP) is a common indication for antibiotic treatment in young children. Data are limited regarding the ideal dose and duration of amoxicillin, leading to practice variation which may impact on treatment failure and antimicrobial resistance (AMR). Community-Acquired Pneumonia: a randomIsed controlled Trial (CAP-IT) aims to determine the optimal amoxicillin treatment strategies for CAP in young children in relation to efficacy and AMR. Methods and analysis The CAP-IT trial is a multicentre, randomised, double-blind, placebo-controlled 2×2 factorial non-inferiority trial of amoxicillin dose and duration. Children are enrolled in paediatric emergency and inpatient environments, and randomised to receive amoxicillin 70-90 or 35-50 mg/kg/day for 3 or 7 days following hospital discharge. The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to 4 weeks after randomisation. Secondary outcomes include adverse events, severity and duration of parent-reported CAP symptoms, adherence and antibiotic resistance. The primary analysis will be by intention to treat. Assuming a 15% primary outcome event rate, 8% non-inferiority margin assessed against an upper one-sided 95% CI, 90% power and 15% loss to follow-up, 800 children will be enrolled to demonstrate non-inferiority for the primary outcome for each of duration and dose. Ethics and dissemination The CAP-IT trial and relevant materials were approved by the National Research Ethics Service (reference: 16/LO/0831; 30 June 2016). The CAP-IT trial results will be published in peer-reviewed journals, and in a report published by the National Institute for Health Research Health Technology Assessment programme. Oral and poster presentations will be given to national and international conferences, and participating families will be notified of the results if they so wish. Key messages will be constructed in partnership with families, and social media will be used in their dissemination. Trial registration number ISRCTN76888927, EudraCT2016-000809-36.

Original languageEnglish
Article numbere029875
JournalBMJ Open
Volume9
Issue number5
DOIs
Publication statusPublished - 1 May 2019

Bibliographical note

Funding Information:
Funding The CAP-IT trial is funded by the NIHR HTA Programme, Antimicrobial Resistance Themed Call, via grant number 13/88/11. University College London (UCL) is the trial sponsor.

Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Keywords

  • antimicrobial resistance
  • community-acquired pneumonia

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