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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001837-35-LT

Enrollment

Registered

2022-08-17

Start date

2023-02-27

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-onset sepsis (LOS) in term and pre-term neonates and infants up to 3 months of age. MedDRA version: 20.1 Level: LLT Classification code 10053598 Term: Late onset neonatal sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Zevtera® Product Name: Ceftobiprole medocaril Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Ceftobiprole medocaril CAS Number: 252188-71-9 Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent from parent(s) or other legally-acceptable representative (LAR) to participate in the study 2. Male or female, with a gestational age of = 24 weeks and a post-natal age ranging from = 3 days to = 3 months 3. Diagnosis of documented or presumed bacterial LOS requiring administration of systemic antibiotic treatment. 4. Sufficient vascular access to receive study drug and to allow blood sampling at a site separate from the study drug infusion line Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Refractory septic shock not responding to 60 minutes of vasopressor treatment within 48 hours before enrollment 2. Proven ventilator-associated pneumonia 3. Proven central nervous system infection (e.g., meningitis, brain abscess) 4. Proven osteomyelitis, infective endocarditis, or necrotising enterocolitis 5. 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 6. Progressively fatal underlying disease, or life expectancy < 30 days 7. Use of systemic antibacterial therapy for longer than 72 hours within 7 days before start of study medication 8. Participation in another clinical study with an investigational product within 30 days of enrollment in the current study

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterise the safety profile of ceftobiprole in term and pre-term neonates and infants up to 3 months of age with LOS.;Secondary Objective: To assess in term and pre-term neonates and infants up to 3 months of age with LOS treated with ceftobiprole: - PK of ceftobiprole - Clinical response - All-cause mortality - Microbiological response;Primary end point(s): The primary endpoint is safety and tolerability in the Safety population, as assessed by adverse events (AEs), serious adverse events (SAEs), deaths, and discontinuations due to AEs during treatment with ceftobiprole and at the end of treatment (EOT), test of cure (TOC), and last follow-up (LFU) visits, as well as clinical laboratory tests, vital signs, and physical examination findings.;Timepoint(s) of evaluation of this end point: At the EOT, TOC, and LFU visits, as well as clinical laboratory tests, vital signs, and physical examination findings.	—

Measure

Time frame

Main Objective: To characterise the safety profile of ceftobiprole in term and pre-term neonates and infants up to 3 months of age with LOS.;Secondary Objective: To assess in term and pre-term neonates and infants up to 3 months of age with LOS treated with ceftobiprole: - PK of ceftobiprole - Clinical response - All-cause mortality - Microbiological response;Primary end point(s): The primary endpoint is safety and tolerability in the Safety population, as assessed by adverse events (AEs), serious adverse events (SAEs), deaths, and discontinuations due to AEs during treatment with ceftobiprole and at the end of treatment (EOT), test of cure (TOC), and last follow-up (LFU) visits, as well as clinical laboratory tests, vital signs, and physical examination findings.;Timepoint(s) of evaluation of this end point: At the EOT, TOC, and LFU visits, as well as clinical laboratory tests, vital signs, and physical examination findings.

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Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetics - Plasma levels of ceftobiprole, ceftobiprole medocaril, and the open-ring metabolite in the PK population Efficacy - Clinical cure rate at the EOT and TOC visits (ITT and CE populations) - All-cause mortality through Day 28 (ITT population) - Microbiological eradication or presumed eradication rate at the EOT and TOC visits (mITT and ME populations) - Improved signs and symptoms of LOS at the Day 3, EOT, and TOC visits (ITT and CE populations);Timepoint(s) of evaluation of this end point: At Day 3, Day 28, EOT and TOC visit.	—

Measure

Time frame

Secondary end point(s): Pharmacokinetics - Plasma levels of ceftobiprole, ceftobiprole medocaril, and the open-ring metabolite in the PK population Efficacy - Clinical cure rate at the EOT and TOC visits (ITT and CE populations) - All-cause mortality through Day 28 (ITT population) - Microbiological eradication or presumed eradication rate at the EOT and TOC visits (mITT and ME populations) - Improved signs and symptoms of LOS at the Day 3, EOT, and TOC visits (ITT and CE populations);Timepoint(s) of evaluation of this end point: At Day 3, Day 28, EOT and TOC visit.

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Countries

Bulgaria, Estonia, Germany, Latvia, Lithuania, Poland, Slovakia, United States

Contacts

Public ContactClinical Operations

Basilea Pharmaceutica International Ltd, Allschwil

medical.information@basilea.com+41616061111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026