drugset / Trial / NCT05856227
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2023-08-06
- Primary completion
- 2024-12-18
- Completion
- 2024-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftobiprole | Small molecule | 7.5 mg/kg | Intravenous |
| Subject | Ceftobiprole | Small molecule | 15 mg/kg | Intravenous |