Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
Completed · Phase 3
Conditions studied: Neonatal Sepsis
In brief
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.
Key facts
- Study ID
- NCT05856227
- Run by
- Basilea Pharmaceutica
- People needed
- 9
- Starts
- 2023-08-06
- Expected to finish
- 2024-12-18
- Last updated by the study team
- 2025-07-28
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
Where it is running
- NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
- West Virginia University — Morgantown, West Virginia, United States
- MHAT Dr. Stamen Iliev AD Montana, Neonatology Department — Montana, Bulgaria
- UMHAT "Sveti Georgi" EAD, Pediatric surgery Clinic — Plovdiv, Bulgaria
- "Acibadem City Clinic University Hospital Tokuda" EAD, Neonatology Department — Sofia, Bulgaria
- Tallinn Childrens' Hospital — Tallinn, Estonia
- Klinikum der Universität München, Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital — Munich, Bavaria, Germany
- Pauls Stradins Clinical University Hospital — Riga, Latvia
- Children Clinical University Hospital - Neonatology Clinic — Riga, Latvia
- Lithuanian Health Science University Hospital Kauno klinikos - Neonatology Clinic — Kaunas, Lithuania
- Vilnius University Hospital Santaros klinikos - Neonatology Center — Vilnius, Lithuania
- Ginekologiczno-Położniczy Szpital Kliniczny im. Marcinkowskiego — Poznan, Poland
- Szpital Uniwersytecki - Klinika Neonatologii — Wroclaw, Poland
- Univerzitna nemocnica Martin — Martin, Slovakia
Full record on ClinicalTrials.gov
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