ProABIS cut two antibiotic days; rare-harm safety remains uncertain

In 504 analyzed newborns with suspected or proven late-onset sepsis, procalcitonin guidance reduced median antibiotic exposure from 10 to 8 days. The trial randomized 511 of 2,162 planned participants, so uncommon harms remain uncertain despite meeting its 3-point mortality noninferiority margin.

The Hot Take

ProABIS gives neonatal stewardship a clear efficacy signal: among 504 analyzed infants with suspected or proven late-onset sepsis, procalcitonin guidance reduced median antibiotic treatment from 10 to 8 days. The safety question is less settled because the trial randomized 511 of the 2,162 participants planned for its mortality analysis.

Non-inferiority for mortality at day 28 should be interpreted with caution.

What was randomized

This was an open-label, 1:1 randomized trial across 33 French level III or IIb neonatal units that enrolled participants. Eligible infants were older than 4 days, born after 24 weeks, weighed at least 700 g after a protocol amendment, had suspected or proven late-onset sepsis, and were already expected to need antibiotics beyond 48 hours. Meningitis, septic shock, endocarditis, abscess, bone infection, and other deep-seated infections were excluded.