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

NCT05856227 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: BPR-PIP-003
• Study Type: interventional
• Target: 9
• Locations: 8 countries
• Sites: 14

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.

Conditions

Neonatal Sepsis

Keywords

Late-onset sepsis; Neonates; Infants

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events (AEs)

  Number of patients with AEs, serious adverse events (SAEs), AEs leading to discontinuations and AEs of special interest

  Up to 5-7 weeks

Secondary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of Ceftobiprole, Ceftobiprole Medocaril, and Open-ring Metabolite

  On treatment Day 3 prior to and 2, 4, and 8 hours after the start of the first ceftobiprole infusion of the day

• Number of Patients With a Clinical Response

  Up to 28 days

• Number of Participants With Improved Signs and Symptoms of Late Onset Sepsis (LOS)

  Up to 28 days

• Number of Patients With a Microbiological Response

  Up to 28 days

Study Arms (1)

Treatment Arm: Ceftobiprole

EXPERIMENTAL

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

Drug: Ceftobiprole medocaril

Interventions

Ceftobiprole medocaril DRUG

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

Treatment Arm: Ceftobiprole

Eligibility Criteria

• Age: 3 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Study Sites (14)

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MHAT Dr. Stamen Iliev AD Montana, Neonatology Department

Montana, 3400, Bulgaria

Location

UMHAT "Sveti Georgi" EAD, Pediatric surgery Clinic

Plovdiv, 4000, Bulgaria

Location

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

Sofia, 1407, Bulgaria

Location

Tallinn Childrens' Hospital

Tallinn, 13419, Estonia

Location

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

Munich, Bavaria, 80337, Germany

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Children Clinical University Hospital - Neonatology Clinic

Riga, 1004, Latvia

Location

Lithuanian Health Science University Hospital Kauno klinikos - Neonatology Clinic

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital Santaros klinikos - Neonatology Center

Vilnius, 08410, Lithuania

Location

Ginekologiczno-Położniczy Szpital Kliniczny im. Marcinkowskiego

Poznan, 60-535, Poland

Location

Szpital Uniwersytecki - Klinika Neonatologii

Wroclaw, 50-556, Poland

Location

Univerzitna nemocnica Martin

Martin, 03659, Slovakia

Location

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

ceftobiprole medocaril

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marc Engelhardt, MD, Study Director
• Organization: Basilea Pharmaceutica International Ltd, Allschwil

marc.engelhardt@basilea.com

+41 79 701 0551

Study Officials

• Marc Engelhardt, MD

  Basilea Pharmaceutica International Ltd, Allschwil

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 12, 2023
• Study Start: August 6, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

LA (2); DE (1); PL (2); BU (3); US (2); LI (2); SL (1); ES (1)