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

NCT ID: NCT05856227

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-06
• Study Completion Date: 2024-12-18

Brief 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.

Detailed 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.

Conditions

Neonatal Sepsis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm: Ceftobiprole

Ceftobiprole medocaril: 7.5 mg/kg to 15 mg/kg

Group Type: EXPERIMENTAL

Ceftobiprole medocaril

Intervention Type: DRUG

Ceftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion.

Interventions

Ceftobiprole medocaril

Ceftobiprole medocaril: 7.5 mg/kg every 12 hours to 15 mg/kg every 8 hours, administered IV as a 2-hour infusion.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Engelhardt, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd, Allschwil

Locations

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

West Virginia University

Morgantown, West Virginia, United States

MHAT Dr. Stamen Iliev AD Montana, Neonatology Department

Montana, , Bulgaria

UMHAT "Sveti Georgi" EAD, Pediatric surgery Clinic

Plovdiv, , Bulgaria

"Acibadem City Clinic University Hospital Tokuda" EAD, Neonatology Department

Sofia, , Bulgaria

Tallinn Childrens' Hospital

Tallinn, , Estonia

Klinikum der Universität München, Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital

Munich, Bavaria, Germany

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Children Clinical University Hospital - Neonatology Clinic

Riga, , Latvia

Lithuanian Health Science University Hospital Kauno klinikos - Neonatology Clinic

Kaunas, , Lithuania

Vilnius University Hospital Santaros klinikos - Neonatology Center

Vilnius, , Lithuania

Ginekologiczno-Położniczy Szpital Kliniczny im. Marcinkowskiego

Poznan, , Poland

Szpital Uniwersytecki - Klinika Neonatologii

Wroclaw, , Poland

Univerzitna nemocnica Martin

Martin, , Slovakia

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BPR-PIP-003

Identifier Type: -

Identifier Source: org_study_id