Optimizing antibiotic choices for newborns with suspected early-onset sepsis
Official title: PROTeCt-NEO: Promoting Optimal Treatment Choices Through Implementation of Antibiotic Stewardship Strategies in Neonates With Suspected Early-Onset Sepsis
Run by Franciscus Gasthuis · NCT06845332 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 3 Days |
| Sex | All |
| Enrollment | 55000 (estimated) |
| Sponsor | Franciscus Gasthuis Academic / other |
| Locations | 11 sites (Alkmaar and 10 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | September 19, 2025 |
| Trial ID | NCT06845332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 5 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.