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

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

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

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