To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
35
Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.
Research Site
Little Rock, Arkansas, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Louisville, Kentucky, United States
Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC
Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were \<6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.
Time frame: Day 1
Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax
Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were \<6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.
Time frame: Day 1
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Research Site
Omaha, Nebraska, United States
Research Site
Akron, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Houston, Texas, United States
Research Site
Morgantown, West Virginia, United States