Effectiveness of biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: the BATCH RCT

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Waldron, CA ORCID: 0000-0001-8465-2492, Pallmann, P ORCID: 0000-0001-8274-9696, Schoenbuchner, S ORCID: 0000-0003-4892-2170, Harris, D ORCID: 0000-0002-7073-7724, Brookes-Howell, L ORCID: 0000-0002-8263-7130, Mateus, C ORCID: 0000-0001-6219-219X, Bernatoniene, J ORCID: 0009-0005-2941-9125, Cathie, K ORCID: 0000-0001-5074-0769, Faust, SN ORCID: 0000-0003-3410-7642, Henley, J ORCID: 0000-0002-2709-900X et al (show 31 more authors) , Hinds, L ORCID: 0000-0002-5042-4368, Hood, K ORCID: 0000-0002-5268-8631, Huang, C ORCID: 0000-0002-3627-7218, Jones, S, Kotecha, S ORCID: 0000-0001-5640-0300, Milosevic, S ORCID: 0000-0003-1973-8286, Nabwera, H ORCID: 0000-0003-1056-729X, Patel, S ORCID: 0000-0001-6329-0496, Paulus, S ORCID: 0000-0002-0703-9114, Powell, CVE ORCID: 0000-0001-8181-875X, Preston, J ORCID: 0000-0003-4800-234X, Xiang, H ORCID: 0000-0002-5515-001X, Thomas-Jones, E ORCID: 0000-0001-7716-2786, Carrol, ED ORCID: 0000-0001-8357-7726, Whitbread, J, Owens, D, Pond, J, Cook, A, Oliver, Z, Douglas, C, Jordan, Z, Hawkins, R, Evans, J, Clarkstone, S, Maboshe, W, Goddard, M, Channon, S, Henley, J, Milosevic, S, Prout, H and Smallman, K (2025) Effectiveness of biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: the BATCH RCT Health Technology Assessment, 29 (16). pp. 1-148. ISSN 1366-5278, 2046-4924

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Abstract

Background: Procalcitonin is a biomarker specific for bacterial infection, with a more rapid response than other commonly used biomarkers, such as C-reactive protein, but it is not routinely used in the National Health Service. Objective: To determine if using a procalcitonin-guided algorithm may safely reduce duration of antibiotic therapy compared to standard of care in hospitalised children with suspected or confirmed infection. Design: A pragmatic, multicentre, open-label, parallel two-arm, individually randomised controlled trial with internal pilot phase, qualitative study and health economic evaluations. Setting: Paediatric wards or paediatric intensive care units within children’s hospitals (n = 6) and district general hospitals (n = 9) in the United Kingdom. Participants: Children aged between 72 hours and 18 years admitted to hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Interventions: Procalcitonin-guided algorithm versus usual standard care alone. Main outcome measures: Coprimary outcomes were duration of intravenous antibiotic use and a composite safety measure. Results: Between 11 June 2018 and 12 October 2022, 1949 children were recruited: 977 to the procalcitonin group [427 female (43.7%), 550 male (56.3%)], and 972 to the usual care group [478 female (49.2%), 494 male (50.8%)]. Duration of intravenous antibiotics was not significantly different between the procalcitonin group (median 96.0 hours) and the usual care group (median 99.7 hours) [hazard ratio = 0.96 (0.87, 1.05)], and the procalcitonin-guided algorithm was non-inferior to usual care [risk difference = −0.81% (95% confidence interval upper bound 1.11%)]. At clinical review, a procalcitonin result was available for 81.8% of the time, which was considered as part of clinical decisionmaking 66.6% of the time, and the algorithm was adhered to 57.2% of the time. Incremental cost-effectiveness ratio per duration of intravenous antibiotics hour avoided from bootstrapped samples was £467.62 per intravenous antibiotic hour avoided. Cost analysis of complete cases was also higher in the procalcitonin arm for all age groups, and for children aged 5 years and over. The intervention is not cost-effective as it is more expensive with no significant improvement in intravenous antibiotic duration. Limitations: Robust antimicrobial stewardship programmes were already implemented in the lead recruiting sites, and adherence to the algorithm was poor. Clinicians may be reluctant to adhere to biomarker-guided algorithms, due to unfamiliarity with interpreting the test result. Conclusions: In children hospitalised with confirmed or suspected bacterial infection, the addition of a procalcitoninguided algorithm to usual care is non-inferior in terms of safety, but does not reduce duration of intravenous antibiotics, and is not cost-effective. In the presence of robust antimicrobial stewardship programmes to reduce antibiotic use, a procalcitonin-guided algorithm may offer little added value. Future work: Future trials must include an implementation framework to improve trial intervention fidelity, and repeated cycles of education and training to facilitate implementation of biomarker-guided algorithms into routine clinical care.

Item Type:	Article
Uncontrolled Keywords:	BATCH trial team, Humans, Bacterial Infections, Anti-Bacterial Agents, Hospitalization, Pilot Projects, Algorithms, Adolescent, Child, Child, Preschool, Infant, Cost-Benefit Analysis, Technology Assessment, Biomedical, Female, Male, Biomarkers, United Kingdom, Procalcitonin
Divisions:	Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Infection, Vet & Ecological Sciences Faculty of Health & Life Sciences > Clinical Directorate
Depositing User:	Symplectic Admin
Date Deposited:	29 Sep 2025 08:16
Last Modified:	28 Feb 2026 01:32
DOI:	10.3310/MBVA3675
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3194642
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