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Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
This prospective observational study is conducted at the First Affiliated Hospital of Zhejiang University School of Medicine from June 1, 2021 to January 1, 2024. The study aims to characterize the population pharmacokinetics of ceftazidime (CAZ) and avibactam (AVI) in critically ill patients receiving ceftazidime-avibactam (CAZ-AVI), including patients with and without renal replacement therapy (RRT). Plasma concentrations of CAZ and AVI will be measured after the first-dose and steady-state administrations. Population pharmacokinetic and pharmacokinetic/pharmacodynamic target-attainment analyses will be performed to explore dosing strategies according to renal function and RRT status.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
33
Start Date
2021-06-01
Completion Date
2023-12-20
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
Ceftazidime-avibactam
Critically ill adult patients (≥18 years) receiving intravenous CAZ-AVI for carbapenem-resistant organism (CRO) infections will be enrolled. Arterial blood samples (3 mL) will be collected at 0, 1, 2, 4, 6, and 8 hours after the first-dose and steady-state CAZ-AVI infusions for measurement of plasma CAZ and AVI concentrations.
Locations (1)
The First Affiliated Hospital,College of Medicine,Zhejiang University
Hangzhou, Zhejiang, China