| Title: |
Procalcitonin-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection in the UK (BATCH): a pragmatic, multicentre, open-label, two-arm, individually randomised, controlled trial |
| Authors: |
Waldron, CA; Pallmann, P; Schoenbuchner, S; Harris, D; Brookes-Howell, L; Mateus, C; Bernatoniene, J; Cathie, K; Faust, SN; Hinds, L; Hood, K; Huang, C; Jones, S; Kotecha, S; Nabwera, HM; Patel, S; Paulus, SC; Powell, CVE; Preston, J; Xiang, H; Thomas-Jones, E; Carrol, ED |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2025 |
| Collection: |
The University of Liverpool Repository |
| Description: |
Background: Procalcitonin is a rapid response biomarker specific for bacterial infection, which is not routinely used in the UK National Health Service. We aimed to assess whether using a procalcitonin-guided algorithm would safely reduce the duration of antibiotic therapy compared with usual care, in which C-reactive protein is the commonly used biomarker. Methods: The BATCH trial was a pragmatic, multicentre, open-label, parallel, two-arm, individually randomised, controlled trial conducted in 15 hospitals in England and Wales. Children aged 72 h to 18 years who were admitted to hospital and were being treated with intravenous antibiotics for suspected or confirmed bacterial infection and who were expected to remain on intravenous antibiotics for more than 48 h were enrolled. Participants were randomly assigned (1:1) to receive either current clinical management alone (usual care group) or clinical management with the addition of a procalcitonin test guided algorithm (procalcitonin group). Participants were randomly assigned by minimisation, with site and age group (0–6 months, 6 months to 2 years, 2–5 years, and older than 5 years) as minimisation factors and a random element to reduce predictability. Participants were randomly assigned remotely using a secure 24 h web-based randomisation programme. The coprimary outcomes were duration of intravenous antibiotic use, assessed for superiority, and a composite safety measure, assessed for non-inferiority (non-inferiority margin 5%). The primary analysis sample for each coprimary endpoint included all randomly assigned participants with available outcome data. This trial is registered with the International Standard Randomised Controlled Trial Number registry, ISRCTN11369832. Findings: Between June 11, 2018, and Oct 12, 2022, 15 282 children were screened for eligibility, 1949 of whom were randomly assigned to receive procalcitonin-guided antibiotic therapy (n=977) or usual care (n=972). The median intravenous antibiotic duration was 96·0 h (IQR 59·5–155·5) in ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
2352-4642 |
| Relation: |
https://livrepository.liverpool.ac.uk/3189709/1/BATCH%20Results%20manuscript%20revised%20FINAL%20accepted%20_02.10.2024.docx; Collapse authors list. Waldron, CA, Pallmann, P, Schoenbuchner, S, Harris, D, Brookes-Howell, L, Mateus, C, Bernatoniene, J, Cathie, K, Faust, SN, Hinds, L et al (show 12 more authors) , Hood, K, Huang, C, Jones, S, Kotecha, S, Nabwera, HM, Patel, S, Paulus, SC, Powell, CVE, Preston, J, Xiang, H, Thomas-Jones, E and Carrol, ED orcid:0000-0001-8357-7726 (2025) Procalcitonin-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection in the UK (BATCH): a pragmatic, multicentre, open-label, two-arm, individually randomised, controlled trial Lancet Child and Adolescent Health, 9 (2). pp. 121-130. ISSN 2352-4642, 2352-4642 |
| DOI: |
10.1016/s2352-4642(24)00306-7 |
| Availability: |
https://livrepository.liverpool.ac.uk/3189709/; https://doi.org/10.1016/s2352-4642(24)00306-7; https://livrepository.liverpool.ac.uk/3189709/1/BATCH%20Results%20manuscript%20revised%20FINAL%20accepted%20_02.10.2024.docx |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.A70FC9B4 |
| Database: |
BASE |