Minder antibiotica bij neonaten met mogelijke sepsis?

Objective

Assessing the safety and effectiveness of the early-onset sepsis (EOS) calculator compared with the categorical guideline in reducing empiric antibiotic treatment in newborns with suspected EOS.

Design

Open-label, cluster-randomised controlled trial in 10 Dutch hospitals, randomised 1:1 to the EOS calculator or the categorical guideline.

Method

1830 newborns (gestational age ≥34 weeks, ≥1 EOS risk factor) were included. Non-inferiority was assessed using four predefined harm criteria (respiratory support, circulatory support, culture-proven EOS, referral to tertiary hospital). Superiority was assessed as reduction of empiric antibiotics <24 hours postpartum.

Results

At least one harm criterion was present in 7.0% (64/915) of the EOS calculator arm, compared to 14.6% (134/915) in the categorical guideline arm (relative risk 0.48; 95% CI 0.36–0.63). Antibiotics were started in 7.2% (66/915) versus 26.6% (243/915), respectively (absolute risk reduction: 19.0%, 95% CI 11.3–26.7).

Conclusion

EOS calculator implementation safely reduces empiric antibiotic use in newborns.

Conflict of interest and financial support: ICMJE forms provided by the authors are available online along with the full text of this article.