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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Treatments: Ceftobiprole; Ceftobiprole medocaril

Criteria

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 necrotising 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 48 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