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

NCT05413343 | Active Not Recruiting FDA Drug

• 1 other identifier: 2022-468
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A observational study is conducting at the First Affiliated Hospital of the Medical College of Zhejiang University from June 1, 2021 to January 1, 2024. Patients with severe sepsis and treatment with Ceftazidime-avibactam (CAZ-AVI) will be enrolled. Blood samples at different time points: 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration will be collected to detect plasma drug concentrations of CAZ-AVI.

Conditions

Severe Sepsis

Keywords

Severe sepsis; Ceftazidime-avibactam; Plasma drug concentration; Population pharmacokinetics (PPK); Pharmacokinetic (PK); Critically ill Patients; Pharmacodynamic (PD)

Outcome Measures

Primary Outcomes (3)

• Plasma drug concentrations of CAZ-AVI

  Plasma drug concentrations of CAZ-AVI after the first time of drug administration

  0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time of drug administration

• Plasma drug concentrations of CAZ-AVI

  Plasma drug concentrations of CAZ-AVI after the steady state concentration (more than 4 times drug administration) of drug administration

  0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the steady state concentration (more than 4 times drug administration) of drug administration

• A population pharmacokinetic (PopPK) model for CAZ-AVI and to propose an appropriate dosing regimen in Chinese critically ill patients.

  By conducting pharmacokinetic and pharmacodynamic analysis on the plasma drug concentration data of patients receiving CAZ-AVI treatment in the intensive care unit, we aim to develop a population pharmacokinetic (PopPK) model for critically ill patients in China and to formulate an appropriate dosing regimen for critically ill patients with varying degrees of renal function, including those undergoing renal replacement therapy.

  After obtaining the patient's plasma drug concentration

Secondary Outcomes (18)

• Serum albumin

  The day of the first time of drug administration

• Serum albumin

  The day of the steady state concentration (more than 4 times drug administration) of drug administration

• The level of creatinine

  The day of the first time of drug administration

• The level of creatinine

  The day of the first time of the steady state concentration (more than 4 times drug administration) of drug administration

• The level of glomerular filtration rate

  The day of the first time of drug administration

Interventions

Ceftazidime-avibactam DRUG

Patients with severe sepsis and treatment with CAZ-AVI will be enrolled. Blood samples at 0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time and the steady state concentration(more than 4 times drug administration) of drug administration will be collected to detect plasma drug concentrations of CAZ-AVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe sepsis and treatment with Ceftazidime-Avibactam in ICU of the First Affiliated Hospital of the Medical College of Zhejiang University from January 1, 2022 to September 30, 2022.

You may qualify if:

• Patients with severe sepsis and treated with ceftazidime avibactam
• Age ≥ 18 years
• The patient or authorized persons agree and sign the informed consent
• The patient's hemoglobin is greater than 70g/l during blood collection

You may not qualify if:

• The expected length of ICU stay less than 48 hours,
• Pregnant woman,
• The blood sample is hemolysis.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital,College of Medicine,Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

avibactam, ceftazidime drug combination

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• YongHong Xiao, PhD

  First Affiliated Hospital of Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: June 1, 2021
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)