PROTeCt-NEO: Promoting Optimal Treatment Choices Through Implementation of Antibiotic Stewardship Strategies in Neonates With Suspected Early-Onset Sepsis

Status: Recruiting
Location: See all (11) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 days
Healthy Volunteers: f
View:

• Neonates born at 34 weeks of gestation or later

• 0-3 days old

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Gelre Ziekenhuis
RECRUITING
Apeldoorn
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Catharina Ziekenhuis
RECRUITING
Eindhoven
Treant Ziekenhuis
RECRUITING
Emmen
Admiraal de Ruyter Ziekenhuis
RECRUITING
Goes
Tjongerschans Ziekenhuis
RECRUITING
Heerenveen
Zuyderland Medisch
RECRUITING
Heerlen
Medisch Centrum Leeuwarden
RECRUITING
Leeuwarden
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Antonius Ziekenhuis Sneek
RECRUITING
Sneek
Contact Information
Primary
Liesanne E. J. Van Veen, MD
+31628138839
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 55000
Treatments
Pre-implementation cohort
Post-implementation cohort
Related Therapeutic Areas
Sponsors
Leads: Franciscus Gasthuis

This content was sourced from clinicaltrials.gov