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NCT05796115: PROPOSE
PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
NA trial testing Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS in Early-Onset Neonatal Sepsis in 266 participants. Status unknown.
31 March 2025
Quick facts
| Lead sponsor | University of Florence |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 266 |
| Start date | 1 April 2023 |
| Primary completion | 31 March 2025 |
| Estimated completion | 30 September 2025 |
Drugs / interventions tested
- Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
- Antibiotic prophylaxis for EOS
Conditions studied
- Early-Onset Neonatal Sepsis — all drugs for Early-Onset Neonatal Sepsis →
Sponsor
University of Florence
Who can join
Adults 0 Hours to 3 Hours, any sex, with Early-Onset Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS). The main question it aims to answer is: • Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH \>3 grade, PVL, ROP \>3 grade in either eye, NEC \>2 grade, BPD, or LOS. Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight \<1500 g will be eligible for enrollment in the study. Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05796115
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05796115 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florence
- Last refreshed: 3 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05796115.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing