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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.

The Lancet. Child & adolescent health2025-01-12PubMed
Total: 76.5Innovation: 6Impact: 8Rigor: 9Citation: 7

Summary

In a multicentre pragmatic RCT of 1,949 hospitalized children, a procalcitonin-guided algorithm did not shorten the duration of IV antibiotics versus usual care and was non-inferior for safety. The findings argue against routine use of procalcitonin-guided algorithms where robust pediatric stewardship is in place.

Key Findings

  • No reduction in IV antibiotic duration: median 96.0 h (PCT) vs 99.7 h (usual care); HR 0.96 (95% CI 0.87–1.05).
  • Safety was non-inferior: composite adverse events in 9% vs 9%; adjusted risk difference −0.81% (95% CI upper bound 1.11, below 5% margin).
  • Pragmatic, multicentre RCT across 15 hospitals randomizing 1,949 children using minimisation with age and site.

Clinical Implications

Do not implement procalcitonin-guided algorithms solely to reduce IV antibiotic duration in pediatric inpatients where strong stewardship exists; maintain current stewardship-based decision-making.

Why It Matters

This is the largest pragmatic pediatric RCT testing procalcitonin-guided therapy against contemporary stewardship, delivering definitive negative evidence that can immediately inform guidelines and policy.

Limitations

  • Open-label design could influence clinician behavior despite objective primary outcome.
  • Findings reflect UK settings with strong stewardship and may not generalize to regions with different practices; focus on IV duration may not capture total antibiotic exposure.

Future Directions

Evaluate procalcitonin or combined biomarker algorithms in settings with less mature stewardship, and identify subgroups (e.g., severe sepsis, immunocompromised) where biomarker guidance may add value.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Multicentre randomized controlled trial providing high-level evidence.
Study Design
OTHER