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Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): Protocol for a randomised controlled trial

Waldron, Cherry-Ann; Thomas-Jones, Emma; Bernatoniene, Jolanta; Brookes-Howell, Lucy; Faust, Saul N; Harris, Debbie; Hinds, Lucy; Hood, Kerenza; Huang, Chao; Mateus, Céu; Pallmann, Philip; Patel, Sanjay; Paulus, Stéphane; Peak, Matthew; Powell, Colin; Preston, Jennifer; Carrol, Enitan D

Authors

Cherry-Ann Waldron

Emma Thomas-Jones

Jolanta Bernatoniene

Lucy Brookes-Howell

Saul N Faust

Debbie Harris

Lucy Hinds

Kerenza Hood

Céu Mateus

Philip Pallmann

Sanjay Patel

Stéphane Paulus

Matthew Peak

Colin Powell

Jennifer Preston

Enitan D Carrol



Abstract

Introduction Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children.
Methods and analysis Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic.

Citation

Waldron, C., Thomas-Jones, E., Bernatoniene, J., Brookes-Howell, L., Faust, S. N., Harris, D., …Carrol, E. D. (2022). Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): Protocol for a randomised controlled trial. BMJ open, 12(1), Article e047490. https://doi.org/10.1136/bmjopen-2020-047490

Journal Article Type Article
Acceptance Date Dec 3, 2021
Online Publication Date Jan 25, 2022
Publication Date 2022-01
Deposit Date Apr 4, 2022
Publicly Available Date Oct 27, 2022
Journal BMJ open
Print ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 12
Issue 1
Article Number e047490
DOI https://doi.org/10.1136/bmjopen-2020-047490
Public URL https://hull-repository.worktribe.com/output/3903344

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Publisher Licence URL
http://creativecommons.org/licenses/by/4.0

Copyright Statement
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.



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