Phase 3
N=9
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
Neonatal Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT05856227 ↗Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Jul 2025
Primary outcome: Primary: Number of Patients With Adverse Events (AEs) — 3; 3; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ceftobiprole medocaril (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
3; 3; 0; 0; 1; 1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite |
17.2; 28.4; 0.585; 0.552; 1.18; 1.68 | — |
| SECONDARY Number of Patients With a Clinical Response |
4; 2; 0; 1; 2; 0 | — |
| SECONDARY Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS) |
1; 1; 1; 0; 3; 1 | — |
| SECONDARY Number of Patients With a Microbiological Response |
4; 1; 0; 1; 0; 1 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05856227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.