BATCH
Trial question
What is the role of procalcitonin-guided algorithm in children hospitalized with suspected or confirmed bacterial infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 1949
1949 patients (905 female, 1044 male).
Inclusion criteria: children, aged 72 hours to 18 years, with suspected or confirmed bacterial infection who were expected to remain on IV antibiotics for > 48 hours.
Key exclusion criteria: receipt of antibiotics for surgical prophylaxis; chronic comorbidities; severe immunocompromised state; high probability of requiring sustained IV antibiotics therapy.
Interventions
N=977 procalcitonin-guided algorithm (clinical management with the addition of a procalcitonin-guided algorithm).
N=972 usual care (current clinical management alone).
Primary outcome
Median duration of IV antibiotic use
96 hours
99.7 hours
99.7 hours
74.8 hours
49.9 hours
24.9 hours
0.0 hours
Procalcitonin-guided
algorithm
Usual
care
No significant
difference ↔
No significant difference in median duration of IV antibiotic use (96 hours vs. 99.7 hours; HR 0.96, 96% CI 0.87 to 1.05).
Secondary outcomes
No significant difference in the rate of unscheduled admissions or readmissions to pediatric ICU with or without infective diagnosis, unplanned readmission to hospital, restarting IV antibiotics within 7 days, or death within 28 days (9% vs. 9%; RR 0.9, 95% CI -Infinity to 1.15).
No significant difference in death (0.6% vs. 1.2%; OR 0.54, 95% CI 0.2 to 1.46).
No significant difference in hospital-acquired infection (2.9% vs. 2.1%; OR 1.38, 95% CI 0.75 to 2.53).
Safety outcomes
No significant difference in suspected adverse drug reaction.
Conclusion
In children, aged 72 hours to 18 years, with suspected or confirmed bacterial infection who were expected to remain on IV antibiotics for > 48 hours, procalcitonin-guided algorithm was not superior to usual care with respect to median duration of IV antibiotic use.
Reference
Cherry-Ann Waldron, Philip Pallmann, Simon Schoenbuchner 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 Feb;9(2):121-130.
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