Clinical trial NCT05856227: Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Sepsis
Keywords: Late-onset sepsis
Neonates
Infants
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate 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 is a multicenter, open-label, single-arm, multiple-dose study of intravenous (IV) ceftobiprole medocaril (prodrug of the active moiety ceftobiprole). It may 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 will be 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 is 3-10 days, which may be extended to 14 days if considered clinically necessary by the Investigator.

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 necrotising 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

Primary outcomes:
measure: Safety and tolerability by incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 5-7 weeks
measure: Number of participants with clinically relevant findings in laboratory tests
timeFrame: Up to 5-7 weeks
measure: Number of participants with clinically relevant findings in vital signs
timeFrame: Up to 5-7 weeks
measure: Number of participants with clinically relevant findings in physical examination
timeFrame: Up to 5-7 weeks
Secondary outcomes:
measure: Observed plasma concentrations of ceftobiprole, ceftobiprole medocaril, and open-ring metabolite
timeFrame: At day 3
measure: Clinical response
timeFrame: 5-7 weeks
measure: All-cause mortality
timeFrame: through Day 28
measure: Microbiological response
timeFrame: 5-7 weeks
measure: Number of participants with improved signs and symptoms of LOS
timeFrame: At the Day 3 and up to 5-7 weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem-Evanston Hospital
state: Illinois
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Montana
country: Bulgaria
facility: MHAT Dr. Stamen Iliev AD Montana, Neonatology Department
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" EAD, Pediatric surgery Clinic
city: Sofia
country: Bulgaria
facility: "Acibadem City Clinic University Hospital Tokuda" EAD, Neonatology Department
city: Tallinn
country: Estonia
facility: Tallinn Childrens' Hospital
city: Munich
country: Germany
facility: Klinikum der Universität München, Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital
state: Bavaria
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Children Clinical University Hospital - Neonatology Clinic
city: Kaunas
country: Lithuania
facility: Lithuanian Health Science University Hospital Kauno klinikos - Neonatology Clinic
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros klinikos - Neonatology Center
city: Poznan
country: Poland
facility: Ginekologiczno-Położniczy Szpital Kliniczny im. Marcinkowskiego
city: Wroclaw
country: Poland
facility: Szpital Uniwersytecki - Klinika Neonatologii
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
Study officials:
affiliation: Basilea Pharmaceutica International Ltd, Allschwil
name: Marc Engelhardt, MD
role: STUDY_DIRECTOR
References: