Procalcitonin-guided decision and antibiotic treatment duration in late onset sepsis of newborns: multicentre, randomised controlled trial (ProABIS).

Summary

In a 33-center randomized trial of 504 neonates with suspected/proven late-onset sepsis, procalcitonin-guided recommendations shortened antibiotic duration (median 8 vs 10 days; P<0.001) without increasing 28-day mortality or recurrence. This supports PCT-based stewardship strategies in neonatal sepsis pathways.

Key Findings

• Antibiotic duration was reduced by a median of 2 days with PCT guidance (8 vs 10 days; P<0.001).
• 28-day mortality was similar: 2.4% (PCT) vs 3.9% (usual care); absolute difference −1.5% (95% CI −5.0 to 1.8).
• Recurrence rates were comparable: 2.8% (PCT) vs 3.9% (usual care).
• Operational protocol used a non-binding stop recommendation when PCT ≤0.5 µg/L, measured every 2 days.

Clinical Implications

Integrate PCT monitoring (threshold ≤0.5 µg/L, assessed every 48 hours) into neonatal late-onset sepsis protocols to safely reduce antibiotic days, while ensuring cultures are obtained and excluding meningitis/shock/deep infections.

Limitations

• Open-label design with non-binding recommendations may introduce clinician-driven variability.
• Exclusion of meningitis, septic shock, and deep-seated infections limits generalizability to all neonatal sepsis cases.

Future Directions

Evaluate implementation at scale, cost-effectiveness, and performance in higher-risk subgroups; refine stopping thresholds and integration with other biomarkers.