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

Basilea Pharmaceutica

Status and phase

Completed

Phase 3

Conditions

Neonatal Sepsis

Treatments

Drug: Ceftobiprole medocaril

Study type

Interventional

Funder types

Industry

Identifiers

NCT05856227

BPR-PIP-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

3 days to 3 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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