Reducing antibiotic use in newborns at risk for early-onset sepsis

Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator: a Cluster Randomized Study (EOS Calculator RCT)

This study is testing a new tool to see if it can help doctors give fewer antibiotics to newborns at risk for early-onset sepsis without putting their health at risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1830 (estimated)
• Ages: N/A to 24 Hours
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 10 sites (Alkmaar and 9 other locations)
• Trial ID: NCT05274776 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the EOS calculator, a tool designed to assess the risk of early-onset sepsis (EOS) in newborns, compared to the current Dutch guidelines for antibiotic therapy. The study will be conducted in multiple hospitals across the Netherlands and will involve newborns aged 0-24 hours who exhibit risk factors or clinical signs of EOS. By using the EOS calculator, the trial seeks to determine if it can safely reduce unnecessary antibiotic exposure while maintaining patient safety. The primary objectives include measuring the reduction in antibiotic use and assessing predefined safety criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are newborns aged 0-24 hours with a postmenstrual age of 34 weeks or more who show at least one risk factor or clinical sign of early-onset sepsis.

Not a fit: Patients with major congenital anomalies or those who cannot effectively communicate due to language barriers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly decrease unnecessary antibiotic exposure in newborns, reducing the risk of antibiotic resistance and associated complications.

How similar studies have performed: Other studies have shown promise in using risk assessment tools for managing early-onset sepsis, suggesting that this approach may be effective, though the EOS calculator itself is a novel application in this context.

Eligibility criteria

Inclusion Criteria:

* postmenstrual age of 34 weeks or more;
* age between 0-24 hours;
* at least one EOS risk factor or clinical sign of infection (suspected of EOS) present within the first 24 hours of life;
* parental/guardian consent.

Exclusion Criteria:

* major congenital anomalies;
* language barrier (lack of effective communication or whenever it hinders understanding).

Where this trial is running

Alkmaar and 9 other locations

• Northwest Clinics — Alkmaar, Netherlands (Recruiting)
• FlevoHospital — Almere, Netherlands (Recruiting)
• Amstelland Hospital — Amstelveen, Netherlands (Recruiting)
• Olvg — Amsterdam, Netherlands (Recruiting)
• Martini Hospital — Groningen, Netherlands (Recruiting)
• Spaarne Hospital — Haarlem, Netherlands (Recruiting)
• Dijklander Hospital — Hoorn, Netherlands (Recruiting)
• Canisius-Wilhelmina Hospital — Nijmegen, Netherlands (Recruiting)
• Máxima Medical Center — Veldhoven, Netherlands (Recruiting)
• Zaans Medical Centre — Zaandam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Frans B. Plötz, MD, PhD — Amsterdam UMC, Tergooi Ziekenhuizen
• Study coordinator: Prof. Frans B. Plötz, MD, PhD

Conditions Early-Onset Sepsis, Neonatal; EOS; early-onset sepsis; neonatal; EOS calculator