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; 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

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. A., Thomas-Jones, E., Bernatoniene, J., Brookes-Howell, L., Faust, S. N., Faust, S. N., Harris, D., Hinds, L., Hood, K., Huang, C., Mateus, C., Pallmann, P., Patel, S., Paulus, S., Peak, M., Powell, C., Preston, J., & 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: Jan 25, 2022
• Deposit Date: Apr 4, 2022
• Publicly Available Date: Apr 4, 2022
• Journal: BMJ Open
• Print ISSN: 2044-6055
• Electronic 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