An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics

BPR-PIP-001

This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.

2016-11-22

2020-02-25

2020-02-25

Terminated

Early phase I

15

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 enrollment * 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 Exclusion Criteria: * Major birth defect or malformation syndrome * Proven presence of an immunodeficiency * HIV or other congenital viral or fungal infection * Significant laboratory abnormalities including: hematocrit \<20%; absolute neutrophil count \<0.5x10⁹/L; platelet count \< 50x10⁹/L; alanine aminotransferase or aspartate aminotransferase \>3 times the age-specific upper limit of normal * Impaired renal function or known significant renal disease * Any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2023-06-05