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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

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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. / Waldron, Cherry-Ann; Pallmann, Philip; Schoenbuchner, Simon et al.
In: The Lancet Child & Adolescent Health, Vol. 9, No. 2, 28.02.2025, p. 121-130.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Waldron, C-A, 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, H, Patel, S, Paulus, S, Powell, C, Preston, J, Xiang, H, Thomas-Jones, E & Carrol, ED 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', The Lancet Child & Adolescent Health, vol. 9, no. 2, pp. 121-130. https://doi.org/10.1016/S2352-4642(24)00306-7

APA

Waldron, C.-A., Pallmann, P., Schoenbuchner, S., Harris, D., Brookes-Howell, L., Mateus, C., Bernatoniene, J., Cathie, K., Faust, S. N., Hinds, L., Hood, K., Huang, C., Jones, S., Kotecha, S., Nabwera, H., Patel, S., Paulus, S., Powell, C., Preston, J., ... Carrol, E. D. (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. The Lancet Child & Adolescent Health, 9(2), 121-130. https://doi.org/10.1016/S2352-4642(24)00306-7

Vancouver

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. The Lancet Child & Adolescent Health. 2025 Feb 28;9(2):121-130. Epub 2025 Jan 22. doi: 10.1016/S2352-4642(24)00306-7

Author

Waldron, Cherry-Ann ; Pallmann, Philip ; Schoenbuchner, Simon 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. In: The Lancet Child & Adolescent Health. 2025 ; Vol. 9, No. 2. pp. 121-130.

Bibtex

@article{1d23de3a8a1a4733baefa93a4d6b81e8,
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",
abstract = "BackgroundProcalcitonin 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.MethodsThe 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.FindingsBetween 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 the procalcitonin group and 99·7 h (61·2–153·8) in the usual care group (hazard ratio 0·96 [95% CI 0·87–1·05]). 78 (9%) of 917 participants in the procalcitonin group and 85 (9%) of 904 participants in the usual care group had at least one event covered by the composite safety outcome measure (estimated adjusted risk difference –0·81% [95% CI upper bound 1·11]).InterpretationIn children with suspected or confirmed bacterial infection admitted to hospitals in England and Wales for intravenous antibiotic treatment of at least 48 h, the introduction of a procalcitonin-guided algorithm did not reduce duration of intravenous antibiotics treatment and is non-inferior to usual care for safety outcomes. Therefore, evidence does not support the use of procalcitonin-guided algorithms where robust effective paediatric antibiotic stewardship programmes are established.",
author = "Cherry-Ann Waldron and Philip Pallmann and Simon Schoenbuchner and Debbie Harris and Lucy Brookes-Howell and Ceu Mateus and Jolanta Bernatoniene and Katrina Cathie and Faust, {Saul N} and Lucy Hinds and Kerenza Hood and Chao Huang and Sarah Jones and Sarah Kotecha and Helen Nabwera and Sanjay Patel and St{\'e}phane Paulus and Colin Powell and Jenny Preston and Huasheng Xiang and Emma Thomas-Jones and Carrol, {Enitan D.}",
year = "2025",
month = feb,
day = "28",
doi = "10.1016/S2352-4642(24)00306-7",
language = "English",
volume = "9",
pages = "121--130",
journal = "The Lancet Child & Adolescent Health",
issn = "2352-4642",
publisher = "Elsevier Science B.V.",
number = "2",

}

RIS

TY - JOUR

T1 - Procalcitonin-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection in the UK (BATCH)

T2 - a pragmatic, multicentre, open-label, two-arm, individually randomised, controlled trial

AU - Waldron, Cherry-Ann

AU - Pallmann, Philip

AU - Schoenbuchner, Simon

AU - Harris, Debbie

AU - Brookes-Howell, Lucy

AU - Mateus, Ceu

AU - Bernatoniene, Jolanta

AU - Cathie, Katrina

AU - Faust, Saul N

AU - Hinds, Lucy

AU - Hood, Kerenza

AU - Huang, Chao

AU - Jones, Sarah

AU - Kotecha, Sarah

AU - Nabwera, Helen

AU - Patel, Sanjay

AU - Paulus, Stéphane

AU - Powell, Colin

AU - Preston, Jenny

AU - Xiang, Huasheng

AU - Thomas-Jones, Emma

AU - Carrol, Enitan D.

PY - 2025/2/28

Y1 - 2025/2/28

N2 - BackgroundProcalcitonin 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.MethodsThe 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.FindingsBetween 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 the procalcitonin group and 99·7 h (61·2–153·8) in the usual care group (hazard ratio 0·96 [95% CI 0·87–1·05]). 78 (9%) of 917 participants in the procalcitonin group and 85 (9%) of 904 participants in the usual care group had at least one event covered by the composite safety outcome measure (estimated adjusted risk difference –0·81% [95% CI upper bound 1·11]).InterpretationIn children with suspected or confirmed bacterial infection admitted to hospitals in England and Wales for intravenous antibiotic treatment of at least 48 h, the introduction of a procalcitonin-guided algorithm did not reduce duration of intravenous antibiotics treatment and is non-inferior to usual care for safety outcomes. Therefore, evidence does not support the use of procalcitonin-guided algorithms where robust effective paediatric antibiotic stewardship programmes are established.

AB - BackgroundProcalcitonin 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.MethodsThe 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.FindingsBetween 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 the procalcitonin group and 99·7 h (61·2–153·8) in the usual care group (hazard ratio 0·96 [95% CI 0·87–1·05]). 78 (9%) of 917 participants in the procalcitonin group and 85 (9%) of 904 participants in the usual care group had at least one event covered by the composite safety outcome measure (estimated adjusted risk difference –0·81% [95% CI upper bound 1·11]).InterpretationIn children with suspected or confirmed bacterial infection admitted to hospitals in England and Wales for intravenous antibiotic treatment of at least 48 h, the introduction of a procalcitonin-guided algorithm did not reduce duration of intravenous antibiotics treatment and is non-inferior to usual care for safety outcomes. Therefore, evidence does not support the use of procalcitonin-guided algorithms where robust effective paediatric antibiotic stewardship programmes are established.

U2 - 10.1016/S2352-4642(24)00306-7

DO - 10.1016/S2352-4642(24)00306-7

M3 - Journal article

VL - 9

SP - 121

EP - 130

JO - The Lancet Child & Adolescent Health

JF - The Lancet Child & Adolescent Health

SN - 2352-4642

IS - 2

ER -