A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety,pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-termneonates and infants up to 3 months of age with late-onset sepsis

Basilea Pharmaceutica International Ltd, Allschwil0 sites15 target enrollmentAugust 17, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ate-onset sepsis (LOS) in term and pre-term neonates andinfants up to 3 months of age.
Sponsor: Basilea Pharmaceutica International Ltd, Allschwil
Enrollment: 15
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

August 17, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Basilea Pharmaceutica International Ltd, Allschwil

•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: 15
•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

•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