CRediT contribution statement
Cherry-Ann Waldron (https://orcid.org/0000-0001-8465-2492): Data curation (supporting), Funding acquisition (equal), Investigation (supporting), Methodology (equal), Project administration (equal), Resources (equal), Supervision (equal), Visualisation (equal), Writing – original draft (equal), Writing – reviewing and editing (equal).
Philip Pallmann (https://orcid.org/0000-0001-8274-9696): Conceptualisation (equal), Data curation (equal), Formal analysis (lead), Methodology (lead), Project administration (equal), Resources (supporting), Software (lead), Supervision (equal), Validation (lead), Visualisation (equal), Writing – original draft (equal), Writing – reviewing and editing (equal).
Simon Schoenbuchner (https://orcid.org/0000-0003-4892-2170): Data curation (equal), Formal analysis (equal), Methodology (supporting), Software (equal), Validation (equal), Visualisation (supporting), Writing – original draft (equal), Writing – reviewing and editing (supporting).
Debbie Harris (https://orcid.org/0000-0002-7073-7724): Data curation (lead), Formal analysis (supporting), Investigation (equal), Methodology (supporting), Project administration (supporting), Resources (equal), Software (supporting), Validation (supporting), Visualisation (equal), Writing – original draft (equal), Writing – reviewing and editing (supporting).
Jolanta Bernatoniene (https://orcid.org/0009-0005-2941-9125): Conceptualisation (equal), Funding acquisition (supporting), Investigation (equal), Methodology (supporting), Resources (supporting), Visualisation (supporting), Writing – reviewing and editing (supporting).
Katrina Cathie (https://orcid.org/0000-0001-5074-0769): Investigation (equal), Methodology (supporting), Resources (supporting), Visualisation (supporting), Writing – reviewing and editing (supporting).
Saul Faust (https://orcid.org/0000-0003-3410-7642): Conceptualisation (equal), Funding acquisition (supporting), Investigation (supporting), Methodology (supporting), Resources (supporting), Visualisation (supporting), Writing – reviewing and editing (supporting).
Helen Nabwera (https://orcid.org/0000-0003-1056-729X): Investigation (equal), Methodology (supporting), Resources (supporting), Visualisation (supporting), Writing – reviewing and editing (supporting).
Sanjay Patel (https://orcid.org/0000-0001-6329-0496): Conceptualisation (equal), Funding acquisition (supporting), Investigation (supporting), Methodology (supporting), Resources (supporting), Visualisation (supporting), Writing – reviewing and editing (supporting).
Stephane Paulus (https://orcid.org/0000-0002-0703-9114): Conceptualisation (equal), Funding acquisition (supporting), Investigation (equal), Methodology (supporting), Resources (supporting), Visualisation (supporting), Writing – reviewing and editing (supporting).
Emma Thomas-Jones (https://orcid.org/0000-0001-7716-2786): Conceptualisation (lead), Data curation (lead), Formal analysis (lead), Funding acquisition (lead), Investigation (lead), Methodology (lead), Project administration (lead), Resources (lead), Supervision (lead), Visualisation (lead), Writing – original draft (lead), Writing – reviewing and editing (lead).
Enitan D Carrol (https://orcid.org/0000-0001-8357-7726): Conceptualisation (lead), Data curation (lead), Formal analysis (lead), Funding acquisition (lead), Investigation (lead), Methodology (lead), Project administration (lead), Resources (lead), Supervision (lead), Visualisation (lead), Writing – original draft (lead), Writing – reviewing and editing (lead).
Acknowledgements
Other members of the trial team
We would like to thank and acknowledge the input from the research teams at Alder Hey Children’s Hospital, Bristol Royal Hospital for Children, Southampton Children’s Hospital, Oxford Children’s Hospital, including Jenny Whitbread, Daniel Owens, Jenny Pond, Amber Cook, Zoe Oliver, Claire Douglas and Zoe Jordan.
We would like to thank and acknowledge Cathy Glover (Core Technician), Dr Debbie Howarth (Senior Technician), Nadia Lewis-Burke (Study Coordinator), Rachael Hawkins (Clinical Research Facilitator), Judith Evans (Former Research Administrator) and Sam Clarkstone (Database Developer).
Additional acknowledgements
We would like to thank and acknowledge the support of MSD in particular, John Butler (Meso Scale Discovery Applications Support).
We would like to thank our BATCH TSC and our IDMC for their continued support.
Trial Steering Committee members
Prof Ann Marie Swart (TSC Chairperson, University of East Anglia), Prof Paul Brocklehurst (Former TSC Chairperson, Bangor University), Dr Colette Smith, (University College London), Dr Phil Shackley (University of Sheffield) and Kelly Chapman (Patient and Public Involvement Representative).
Independent Data Monitoring Committee members
Prof Graeme MacLennan (IDMC Chairperson, University of Aberdeen), Prof Alastair Sutcliffe (University College London), Prof Philip Howard (University of Leeds) and Danielle Horton Taylor (Patient and Public Involvement Representative).
Research networks
We would like to thank the providers of nursing/clinical studies officer and administrative support in all sites. These include staff at the local NIHR Clinical Research Networks.
Recruiting sites
We would like to thank all the staff involved at our participating sites including Principal Investigators, Clinicians, Laboratory staff, Research Nurses, Research coordinators and Administrators from:
Alder Hey Children’s NHS Foundation Trust
Oxford University Hospitals NHS Foundation Trust
University Hospitals Bristol and Weston NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Finally, we would like to thank the children and families who participated, without whom this trial would not have been possibleFinal approval was given by Professor Enitan D Carrol, University of Liverpool and Dr Emma Thomas-Jones, Cardiff University, as co-chief investigators of the PRECISE study.
Patient data statement
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it is important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives To find out more about the background to this citation, please visit this link: https://understandingpatientdata.org.uk/data-citation
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Ethics statement
The BATCH trial had ethical approval granted by a NHS REC, recognised by the UKECA. The initial approval of the BATCH trial was granted by the North West Liverpool East REC on 12 April 2018, reference number 18/NW/0100. Approval for the amendment to include the PRECISE substudy was granted by the North West Liverpool Central REC on 9 October 2020.
Information governance statement
Cardiff University is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation Cardiff University is the Data Processor; University of Liverpool is the Data Controller, and we process personal data in accordance with their instructions. You can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for the Data Protection Officer here: www.cardiff.ac.uk/public-information/policies-and-procedures/data-protection.
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/GJEC0818.
Primary conflicts of interest: Philip Pallmann is a member of the MRC-NIHR EME Funding Committee.
Saul Faust was Chair of UK NICE Sepsis (2014–6) and Lyme Disease Guidelines (adult and children) (2016–8), was a member of the HTA Commissioning Committee (2018–24) and is a NIHR Senior Investigator.
Emma Thomas-Jones is a member of the NIHR PGfAR Funding Committee.
Enitan D Carrol was a member of NIHR Invention for Innovation panel (November 2011–23), member of NICE Diagnostic Advisory Committee (April 2014–September 2020), MRC DPFS panel (March 2020–3) and MRC COVID-19 Agile panel (July 2020–1) and is a NIHR Senior Investigator.
The CTR receives infrastructure funding from Health and Care Research Wales.
All other authors declare no competing interests.
Copyright and credit statement
Every effort has been made to obtain the necessary permissions for reproduction, to credit original sources appropriately and to respect copyright requirements. However, despite our diligence, we acknowledge the possibility of unintentional omissions or errors and we welcome notifications of any concerns regarding copyright or permissions.
Publications
Waldron CA, Thomas-Jones E, Bernatoniene J, Brookes-Howell L, Faust SN, Harris D, et al. Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial. BMJ Open 2022;12:e047490. https://doi.org/10.1136/bmjopen-2020-047490
Schoenbuchner SM, Huang C, Waldron CA, Thomas-Jones E, Hood K, Carrol ED, et al. Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: statistical analysis plan for the BATCH trial and PRECISE sub-study. Trials 2023;24:364. https://doi.org/10.1186/s13063-022-06956-9
Waldron CA, Pallmann P, Schoenbuchner S, Harris D, Brookes-Howell L, Mateus C, et al. 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 Adolesc Health 2025;9:121–30. https://doi.org/10.1016/S2352-4642(24)00306-7
Waldron CA, Pallmann P, Schoenbuchner S, Harris D, Brookes-Howell L, Mateus C, et al. Effectiveness of biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: the BATCH RCT. Health Technol Assess 2025;29:1–125. https://doi.org/10.3310/MBVA3675