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

Neonatal Sepsis Clinical Trial

Official title: 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 Recruiting

Clinical Trial Summary

This study will evaluate 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.

Clinical Trial Description

This is a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It may 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 will be 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 is 7-10 days, which may be either extended to 14 days if considered clinically necessary by the Investigator or may be may be stopped after 5 days at the discretion of the Investigator based on resolution of signs and symptoms of sepsis and blood inflammation markers, in accordance with local standard of care. ;

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

• NCT number: NCT05856227
• Study type: Interventional
• Source: Basilea Pharmaceutica
• Contact: Marc Engelhardt, MD
• Phone: +41 79 701 0551
• Email: marc.engelhardt@basilea.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 6, 2023
• Completion date: December 2024