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

Phase 1

• Conditions: documented or presumed bacterial infections, or at risk of a bacterial infection; MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862; MedDRA version: 21.1Level: LLTClassification code 10052596Term: Nosocomial pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-004614-18-LV
• Lead Sponsor: Basilea Pharmaceutica International Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-22
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

- Neonates and infants up to 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

· 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to characterize the pharmacokinetics of a single dose of ceftobiprole in neonates and infants aged up to 3 months. ;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of ceftobiprole in neonates and infants aged up to 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<br>-15 min<br>Pre dose<br>0 to 2 h<br>1 h<br>2 h<br>2 h 15 min<br>2 to 4 h<br>4 h (end of infusion)<br>4 to 8h<br>6h<br>8h<br>8 to 12h<br>12h<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety ;Timepoint(s) of evaluation of this end point: Day -1<br>Day 1<br>Day 7