A pharmacokinetic study to see the effect of Zevtera, a new infusion antibiotic, in babies younger than or equal 3 months.

An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged = 3 Months Undergoing Treatment with Systemic Antibiotics

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004614-18-BE

Enrollment

Registered

2014-05-21

Start date

2014-07-30

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

documented or presumed bacterial infections, or at risk of a bacterial infection MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862 MedDRA version: 21.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia System Organ Class: 100000004862

Interventions

Trade Name: Mabelio© Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: CEFTOBIPROLE MEDOCARIL SODIUM CAS Number: 252188-71-9 Other descriptive name: CEFTOBIPRO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Neonates and infants = 3 months, with gestational age = 28 weeks - Documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment - Expected to survive beyond the first 7 days after enrolment - Sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site - Parent’s / legally acceptable representative’s informed consent to participate in the study Are the trial subjects under 18? yes Number of subjects for this age range: 45 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: · Major birth defect or malformation syndrome · Proven presence of an immunodeficiency · HIV or other congenital viral or fungal infection · Significant laboratory abnormalities · Impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula or other applicable formula) less than 2/3 of normal for the applicable age group · Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to characterize the pharmacokinetics of a single dose of ceftobiprole in neonates and infants aged = 3 months. ;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of ceftobiprole in neonates and infants aged = 3 months.;Primary end point(s): Analyse plasma and urine for concentrations of ceftobiprole, and if applicable for concentrations of ceftobiprole medocaril and the open-ring metabolite (BAL1029). ;Timepoint(s) of evaluation of this end point: -2 to 0 h -15 min Pre dose 0 to 2 h 1 h 2 h 2 h 15 min 2 to 4 h 4 h (end of infusion) 4 to 8 h 6 h 8 h 8 to 12 h 12 h	—

Measure

Time frame

Main Objective: The primary objective is to characterize the pharmacokinetics of a single dose of ceftobiprole in neonates and infants aged = 3 months. ;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of ceftobiprole in neonates and infants aged = 3 months.;Primary end point(s): Analyse plasma and urine for concentrations of ceftobiprole, and if applicable for concentrations of ceftobiprole medocaril and the open-ring metabolite (BAL1029). ;Timepoint(s) of evaluation of this end point: -2 to 0 h -15 min Pre dose 0 to 2 h 1 h 2 h 2 h 15 min 2 to 4 h 4 h (end of infusion) 4 to 8 h 6 h 8 h 8 to 12 h 12 h

—

Secondary

Measure	Time frame
Secondary end point(s): Safety ;Timepoint(s) of evaluation of this end point: Day -1 Day 1 Day 7	—

Countries

Belgium, Germany, Latvia, Lithuania, Poland, United States

Contacts

Public ContactDr Agnes Kaelin Aebi

Basilea Pharmaceutica International Ltd.

Agnes.KaelinAebi@basilea.com4161567 15 34

Outcome results

None listed

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