NCT05856227

Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age

A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 3 Days – 3 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It could be combined with ampicillin and/or an aminoglycoside based on the Investigator's judgement according to manufacturer's instructions and/or local standard of care. Following screening, ceftobiprole was administered as a 2-hour infusion at a dose of 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, depending on age and weight. The target treatment duration was 3-10 days, which could be extended to 14 days if considered clinically necessary by the Investigator.

Conditions

• Neonatal Sepsis

Interventions

Type	Name	Description
DRUG	Ceftobiprole medocaril	Ceftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion.

Timeline

• Start date: 2023-08-06
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2023-05-12
• Last updated: 2025-07-28
• Results posted: 2025-07-28

Locations

14 sites across 8 countries: United States, Bulgaria, Estonia, Germany, Latvia, Lithuania, Poland, Slovakia

Regulatory

• FDA-regulated drug study