Overview
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.
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.
Eligibility
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