Clinical trial Recruiting at 11 sites Observational Ages Any age to 3 Days

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 typeObservational
AgesAny age to 3 Days
SexAll
Enrollment55000 (estimated)
SponsorFranciscus Gasthuis
Academic / other
Locations11 sites (Alkmaar and 10 other locations)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedJune 1, 2026
Study endsJune 1, 2026
Registry record updatedSeptember 19, 2025
Trial IDNCT06845332 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Shorter ampicillin course for preterm infants with early onset sepsis

    This study tests whether stopping ampicillin at 24–36 hours is safe and provides enough drug exposure in preterm babies who are already getting the medicine.

    Recruiting Phase 1/2 Duke University · Durham, North Carolina · NCT07610486

  • Gentamicin dosing in neonates: checking if extended-interval dosing still works

    This study checks whether extended-interval gentamicin dosing in newborns up to 7 days old still achieves safe and effective drug levels.

    Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07460349

  • Investigating how obesity affects severe COVID-19

    This study is trying to see how obesity affects the immune response and severity of COVID-19 by comparing blood samples from obese patients and non-obese healthcare workers.

    Recruiting Franciscus Gasthuis · Rotterdam, South Holland · NCT06968442

  • High Flow Nasal Oxygen for COPD Exacerbations

    This study is testing if High Flow Nasal Oxygen can help people with COPD flare-ups just as well as non-invasive ventilation, while being easier to use and more comfortable.

    Recruiting Franciscus Gasthuis · Delft and 3 other locations · NCT06084117

  • Digital health program for managing severe asthma

    This study is testing a digital health program to help people with severe asthma manage their condition better by using tools like a digital inhaler and activity tracker.

    Recruiting Phase 3 Franciscus Gasthuis · Rotterdam, South Holland · NCT05831566

  • Comparing single and multiple inhalers with digital support for COPD management

    This study is testing whether using one inhaler instead of multiple ones, along with digital support, helps people with COPD stick to their medication better.

    Recruiting Franciscus Gasthuis · Rotterdam, South Holland · NCT05495698

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.