Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Enrollment: 33

Sponsor: First Affiliated Hospital of Zhejiang University

Location: The First Affiliated Hospital,College of Medicine,Zhejiang University Hangzhou Zhejiang

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.

Eligibility Criteria

Inclusion Criteria: * Critically ill patients with severe sepsis(CRO infections) and treated with CAZ-AVI(culture-confirmed CRO susceptible to CAZ-AVI); * Age ≥ 18 years; * Expected ICU stay ≥48 hours. * Hemoglobin \>70 g/L during the pharmacokinetic blood-sampling period； * The patient or authorized persons agree and sign the informed consent. Exclusion Criteria: * Expected ICU stay \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05413343). StuddyBuddy aggregates publicly available trial information.