Pharmacokinetics and Safety of Ceftazidime-Avibactam in Neonates and Young Infants: A Phase 2a, Multicenter Prospective Trial.

ABSTRACT:

Background

This phase 2a study evaluated pharmacokinetics and safety of ceftazidime-avibactam (CAZ/AVI; combination dosed as fixed 4:1 ratio) in neonates and young infants with suspected/confirmed infections due to Gram-negative pathogens requiring intravenous antibiotics.

Methods

Hospitalized neonates and infants (gestational age ≥ 26 weeks to < 3 months), enrolled sequentially into 3 age cohorts, received CAZ/AVI single dose (Part A) or multiple dose every 8 h (Part B) by 2-h intravenous infusions. Infants > 28 days (Cohort 1) received CAZ/AVI 37.5 mg/kg/dose (CAZ 30 mg/kg and AVI 7.5 mg/kg). Full-term neonates ≤ 28 days (Cohort 2) and preterm neonates ≤ 28 days (Cohort 3) received 25 mg/kg/dose (CAZ 20 mg/kg and AVI 5 mg/kg). Pharmacokinetics, safety, and clinical and mic

SUBMITTER: Bradley J 

PROVIDER: S-EPMC12117184 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature