Procalcitonin guided algorithm not effective in reducing intravenous antibiotic duration among kids: Study

Duration and safety of antibiotics are important considerations in the treatment of hospitalised children suffering from bacterial infections. C-reactive protein is used widely in the UK National Health Service as a biomarker of bacterial infection. However, the more specific biomarker for bacterial infections, procalcitonin, is not used on a routine basis. The aim of the BATCH trial was to see whether an addition of procalcitonin-guided management would safely shorten the duration of antibiotic therapy.

The BATCH trial was a pragmatic, multicentre, open-label randomised controlled trial conducted from June 2018 to October 2022 in 15 hospitals in England and Wales. Participants included children from 72 hours of age up to 18 years of age admitted for suspected or confirmed bacterial infections who were required to have intravenous antibiotics for at least 48 hours. Participants (n=1949) were randomly assigned 1:1 to either a standard clinical care group (usual care group, n=972) or a procalcitonin-guided algorithm group (procalcitonin group, n=977). Minimization was used at randomization to adjust for site and age group (0–6 months, 6 months–2 years, 2–5 years, and >5 years). The coprimary outcomes studied were intravenous antibiotic use days and a composite safety endpoint.

Results

• Of the 15,282 children screened, 1949 were enrolled, of whom 977 were assigned to the procalcitonin group and 972 to the usual care group.

• The median duration was 96.0 hours (IQR 59.5–155.5) in the procalcitonin group and 99.7 hours (IQR 61.2–153.8) in the usual care group.

• The hazard ratio for the comparison of the two groups for antibiotic duration was 0.96 (95% CI: 0.87–1.05).

• In the procalcitonin group, 78 of 917 participants (9%) had events included in the composite safety outcome measure.

• Likewise, 85 of 904 participants (9%) in the usual care group had such events.

• The adjusted risk difference was –0.81% (95% CI upper bound: 1.11), thus meeting the predefined non-inferiority margin of 5%.

The BATCH trial concluded that a procalcitonin-guided algorithm neither significantly reduces the duration of intravenous antibiotic therapy nor offers safety advantages over usual care in hospitalized children with suspected bacterial infections. These findings highlight the efficacy of existing pediatric antibiotic stewardship programs in ensuring optimal treatment outcomes.

Reference:

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. M., Patel, S., Paulus, S. C., Powell, C. V. E., Preston, J., … Rojas-Jimenz, E. (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. https://doi.org/10.1016/s2352-4642(24)00306-