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

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.

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.

Key Inclusion Criteria:

• Informed consent from parent(s) or other legally acceptable representative (LAR) to participate in the study
• Male or female, with a gestational age of ≥ 24 weeks and a post-natal age ranging from ≥ 3 days to ≤ 3 months
• Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment
• Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line

Key Exclusion Criteria:

• Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment
• Proven ventilator-associated pneumonia
• Proven central nervous system infection (e.g., meningitis, brain abscess)
• Proven osteomyelitis, infective endocarditis, or necrotizing enterocolitis
• Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) calculated to be less than 2/3 of normal for the applicable age group, OR urinary output < 0.5 mL/kg/h (measured over at least 8 hours), OR requirement for dialysis
• Progressively fatal underlying disease, or life expectancy < 30 days
• Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication
• Participation in another clinical study with an investigational product within 30 days of enrollment in the current study