Optimizing antibiotic choices for newborns with suspected early-onset sepsis
PROTeCt-NEO: Promoting Optimal Treatment Choices Through Implementation of Antibiotic Stewardship Strategies in Neonates With Suspected Early-Onset Sepsis
This project will try three proven hospital approaches—the EOS calculator, procalcitonin-guided therapy, and switching from IV to oral antibiotics—to reduce unnecessary antibiotic use in newborns born at 34+ weeks who are 0–3 days old with suspected early-onset sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55000 (estimated) |
| Ages | N/A to 3 Days |
| Sex | All |
| Sponsor | Franciscus Gasthuis Academic / other |
| Locations | 11 sites (Alkmaar and 10 other locations) |
| Trial ID | NCT06845332 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, non-randomized pre–post implementation study in Dutch hospitals. A bundled antibiotic stewardship program combining the EOS calculator, PCT-guided therapy, and IV-to-oral switch protocols will be actively implemented using a multicomponent strategy. Clinical and implementation outcomes will be compared before and after rollout, with attention to antibiotic use, duration of therapy, safety outcomes, and adherence to the interventions. The aim is to reduce variation in care and safely decrease unnecessary antibiotic exposure in newborns.
Who should consider this trial
Good fit: Newborns born at 34 weeks of gestation or later, aged 0–3 days, who are being evaluated for suspected early-onset sepsis are ideal candidates.
Not a fit: Preterm infants under 34 weeks, babies older than 3 days, stillborn infants, or those with confirmed severe infections requiring prolonged IV therapy may not receive benefit from these protocols.
Why it matters
Potential benefit: If successful, it could safely reduce unnecessary antibiotic exposure and shorten hospital stays for many newborns while maintaining effective infection management.
How similar studies have performed: The EOS calculator and PCT-guided approaches have been implemented elsewhere and shown to safely reduce antibiotic use, and this study applies those strategies together across multiple centers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates born at 34 weeks of gestation or later * 0-3 days old Exclusion Criteria: * stillborn neonates
Where this trial is running
Alkmaar and 10 other locations
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (Recruiting)
- Gelre Ziekenhuis — Apeldoorn, Netherlands (Recruiting)
- Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
- Treant Ziekenhuis — Emmen, Netherlands (Recruiting)
- Admiraal de Ruyter Ziekenhuis — Goes, Netherlands (Recruiting)
- Tjongerschans Ziekenhuis — Heerenveen, Netherlands (Recruiting)
- Zuyderland Medisch — Heerlen, Netherlands (Recruiting)
- Medisch Centrum Leeuwarden — Leeuwarden, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Antonius Ziekenhuis Sneek — Sneek, Netherlands (Recruiting)
Study contacts
- Study coordinator: Liesanne E. J. Van Veen, MD
- Phone: +31628138839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.