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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)

Research output: Contribution to journalArticle

  • Mark D Lyttle
  • Julia Bielicki
  • Sam Barratt
  • David Dunn
  • Adam Finn
  • Lynda Harper
  • Pauline Jackson
  • Colin VE Powell
  • Damian Roland
  • Wolfgang Stöhr
  • Kate Sturgeon
  • Mandy Wan
  • Paul Little
  • Saul N Faust
  • Julie Robotham
  • Alastair Hayhttp://orcid.org/0000-0003-3012-375X
  • Diana M Gibb
  • Mike Sharland
  • On behalf of PERUKI, GAPRUKI and the CAP-IT trial team
Original languageEnglish
Article numbere029875
Number of pages10
JournalBMJ Open
Volume9
Issue number5
Early online date22 May 2019
DOIs
DateAccepted/In press - 21 Mar 2019
DateE-pub ahead of print - 22 May 2019
DatePublished (current) - 22 May 2019

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 Trail (CAP-IT) aims to determine optimal amoxicillin treatment strategies for CAP in young children in relation to efficacy and AMR.

Methods and analysis
The CAP-IT trial is a multi-centre randomised double blind placebo-controlled 2x2 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 mg/kg/day or 35-50 mg/kg/day for three or seven days following hospital discharge. The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to four 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% confidence interval, 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; 30th 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 (NIHR HTA) 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 utilised in their dissemination.

Trial registration
ISRCTN identifier: ISRCTN76888927 (15/12/2015)
EudraCT identifier: 2016-000809-36 (22/02/2016)

Additional information

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

    Research areas

  • community aquired pneumonia, children, amoxicillin, antibiotic treatment

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