Conditions: Systemic Infections
Keywords: Ceftazidime, Avibactam, Anti-Infectives
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.

Detailed description:
This is a phase I, open-label, single-dose study. The study aims to characterize the pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV dose given to hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection. This study will include 4 cohorts, each consisting of at least 8 evaluable pediatric patients, aged ≥3 months to \<18 years, who are hospitalized with infections.

Arms:
arm 1: This arm will include 4 cohorts. Patients will be stratified by age.

Interventions: intervention 1: CAZ-AVI
Intervention descriptions: intervention 1: Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.

Protocol document: