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Study identifier: NCT06845332 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis

Condition: Early-onset Sepsis  ·  Sponsor: Franciscus Gasthuis

PhaseN/A
Planned participants55000
Who can joinAll sexes, N/A to 3 Days
Healthy volunteersNo

About this study

In this study, three neonatal evidence-based antibiotic stewardship strategies will be implemented in Dutch hospitals. These include the early-onset sepsis (EOS) calculator, procalcitonin (PCT)-guided therapy, and IV-to-oral switch therapy. These strategies have been proven to be effective and safe and are already applied in several Dutch hospitals. However, this is not the case for all hospitals, leading to significant variations in clinical practice. To facilitate the translation of evidence into practice, active implementation will take place. The primary research design is a prospective implementation study, using a multicenter, non-randomized pre-post design. The aim is to assess the impact of implementing a bundle of antibiotic stewardship interventions (including the EOS calculator, PCT-guided therapy and iv-to-oral switch therapy) in Dutch hospitals, using a multicomponent implementation strategy, on both clinical and implementation outcomes, with a particular focus on evaluating the employed implementation strategies. A combination of qualitative and quantitative research methods will be used to assess outcomes. Quantitative clinical data from neonates in the pre- and post-implementation periods will be retrospectively collected by the Business Intelligence units of participating hospitals and anonymized before being provided to the central research team. Qualitative data will be gathered through focus groups, interviews, and surveys.

This description comes directly from the study's public registry record.

Talk to the study team

Liesanne E. J. Van Veen, MD  ·  +31628138839

Always discuss trial participation with your own doctor first.

Locations (11)

Noordwest ZiekenhuisgroepAlkmaar, NetherlandsRecruiting
Gelre ZiekenhuisApeldoorn, NetherlandsRecruiting
Albert Schweitzer ZiekenhuisDordrecht, NetherlandsRecruiting
Catharina ZiekenhuisEindhoven, NetherlandsRecruiting
Treant ZiekenhuisEmmen, NetherlandsRecruiting
Admiraal de Ruyter ZiekenhuisGoes, NetherlandsRecruiting
Tjongerschans ZiekenhuisHeerenveen, NetherlandsRecruiting
Zuyderland MedischHeerlen, NetherlandsRecruiting
Medisch Centrum LeeuwardenLeeuwarden, NetherlandsRecruiting
Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsRecruiting
Antonius Ziekenhuis SneekSneek, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT06845332