Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics

• Status: Terminated
• Trial end date: 2020-02-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Treatments: Anti-Bacterial Agents; Ceftobiprole; Ceftobiprole medocaril; Cephalosporins

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 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