Clinical trial NCT06845332: Promoting Optimal Treatment Choices in Neonates 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early-onset Sepsis
Keywords: early-onset sepsis
neonatal sepsis
early-onset sepsis calculator
PCT-guided therapy
iv-to-oral switch therapy
implementation
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 55000
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population neonates with a minimum postmenstrual age of 34 weeks, between 0-3 days old

Brief 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 pseudonymized before being provided to the central research team. Qualitative data will be gathered through focus groups, interviews, and surveys.


Eligibility criteria: Inclusion Criteria:

* Neonates born at 34 weeks of gestation or later
* 0-3 days old

Exclusion Criteria:

* stillborn neonates

Primary outcomes:
measure: Days on therapy
timeFrame: 12 months pre-implementation and 12 months post-implementation
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Emmen
country: Netherlands
facility: Treant Ziekenhuis
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Heerenveen
country: Netherlands
facility: Tjongerschans Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis Sneek
Study officials:
References:
citation: Achten NB, Klingenberg C, Benitz WE, Stocker M, Schlapbach LJ, Giannoni E, Bokelaar R, Driessen GJA, Brodin P, Uthaya S, van Rossum AMC, Plotz FB. Association of Use of the Neonatal Early-Onset Sepsis Calculator With Reduction in Antibiotic Therapy and Safety: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Nov 1;173(11):1032-1040. doi: 10.1001/jamapediatrics.2019.2825.
citation: Keij FM, Kornelisse RF, Hartwig NG, van der Sluijs-Bens J, van Beek RHT, van Driel A, van Rooij LGM, van Dalen-Vink I, Driessen GJA, Kenter S, von Lindern JS, Eijkemans M, Stam-Stigter GM, Qi H, van den Berg MM, Baartmans MGA, van der Meer-Kappelle LH, Meijssen CB, Norbruis OF, Heidema J, van Rossem MC, den Butter PCP, Allegaert K, Reiss IKM, Tramper-Stranders GA. Efficacy and safety of switching from intravenous to oral antibiotics (amoxicillin-clavulanic acid) versus a full course of intravenous antibiotics in neonates with probable bacterial infection (RAIN): a multicentre, randomised, open-label, non-inferiority trial. Lancet Child Adolesc Health. 2022 Nov;6(11):799-809. doi: 10.1016/S2352-4642(22)00245-0. Epub 2022 Sep 9.
citation: Stocker M, van Herk W, El Helou S, Dutta S, Fontana MS, Schuerman FABA, van den Tooren-de Groot RK, Wieringa JW, Janota J, van der Meer-Kappelle LH, Moonen R, Sie SD, de Vries E, Donker AE, Zimmerman U, Schlapbach LJ, de Mol AC, Hoffman-Haringsma A, Roy M, Tomaske M, Kornelisse RF, van Gijsel J, Visser EG, Willemsen SP, van Rossum AMC; NeoPInS Study Group. Procalcitonin-guided decision making for duration of antibiotic therapy in neonates with suspected early-onset sepsis: a multicentre, randomised controlled trial (NeoPIns). Lancet. 2017 Aug 26;390(10097):871-881. doi: 10.1016/S0140-6736(17)31444-7. Epub 2017 Jul 12.