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-BE
• Lead Sponsor: Basilea Pharmaceutica International Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-21
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

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

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

· 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