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

A observational study is conducting at the First Affiliated Hospital of the Medical College of Zhejiang University from January 1, 2022 to January 1, 2024. Patients with severe sepsis and treatment with Ceftazidime-Avibactam will be enrolled.

Blood samples at different timepoints: 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 ceftazidime avibactam.

Study Overview

• Status: Recruiting
• Conditions: Severe Sepsis
• Intervention / Treatment: Drug: Ceftazidime-avibactam

Detailed Description

The investigators will collect the blood samples at different timepoints: 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 from the patients receive treatment with Ceftazidime-Avibactam to detect plasma drug concentrations of ceftazidime avibactam. The collected specimens will be stored in a refrigerator at 0-8 °C, centrifuges within 24 hours (4 °C, 4000 r/min, 10 min), and the supernatant will be collected in an EP tube and stored at -80°C until subsequent analysis. Ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS) will be used to detect plasma drug concentrations of ceftazidime avibactam. According to the outcomes ,the investigators will analyze the following items,(1)T>MIC,(2)Cmax/MIC,(3)AUC/MIC,(4)population pharmacokinetics.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Juan Hu, Master; Phone Number: +86-18758187703; Email: 15151041@zju.edu.cn
• Study Contact Backup: Name: YongHong Xiao, PhD; Phone Number: +86-15168338848; Email: xiaoyonghong@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital,College of Medicine,Zhejiang University
      • Contact: Juan Hu, Master; Phone Number: +86-18758187703; Email: 1515051@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma drug concentrations of ceftazidime avibactam	Plasma drug concentrations of ceftazidime avibactam 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 ceftazidime avibactam	Plasma drug concentrations of ceftazidime avibactam 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum albumin	The level of serum albumin on the day of the first time of drug administration	The day of the first time of drug administration
Serum albumin	The level of serum albumin on the day of the steady state concentration(more than 4 times drug administration) of drug administration	The day of the steady state concentration (more than 4 times drug administration) of drug administration
The level of creatinine	The level of creatinine on the day of the first time of drug administration	The day of the first time of drug administration
The level of creatinine	The level of creatinine on the day of the steady state concentration(more than 4 times drug administration) of drug administration	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 level of glomerular filtration rate on the day of the first time of drug administration	The day of the first time of drug administration
The level of glomerular filtration rate	The level of glomerular filtration rate on the day of the steady state concentration (more than 4 times drug administration) of drug administration	The day of the steady state concentration (more than 4 times drug administration) of drug administration
Whether received renal replacement therapy	Whether the patient received renal replacement therapy on the day of the first time of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no).	The day of the first time of drug administration
Whether received renal replacement therapy	Whether the patient received renal replacement therapy on the day of the steady state concentration (more than 4 times drug administration) of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no).	The day of the steady state concentration (more than 4 times drug administration) of drug administration
Respiratory function	Whether the patient received mechanical ventilation on the day of the first time of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no).	The day of the first time of administration
Respiratory function	Whether the patient received mechanical ventilation on the day of the steady state concentration (more than 4 times drug administration) of drug administration, and the results are recorded in the form of categorical variables,(e.g.,yes or no).	The day of the steady state concentration (more than 4 times drug administration) of drug administration
Cardiovascular function	Whether the patient received vasoactive agents(including norepinephrine, epinephrine, dobutamine, and metarylamine), and the results are recorded in the form of categorical variables,(e.g.,yes or no).	The day of the first time of drug administration
Cardiovascular function	Whether the patient received vasoactive agents(including norepinephrine, epinephrine, dobutamine, and metarylamine), and the results are recorded in the form of categorical variables,(e.g.,yes or no).	The day of the steady state concentration (more than 4 times drug administration) of drug administration

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Study Chair: YongHong Xiao, PhD, First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: severe sepsis; ceftazidime avibactam; plasma drug concentration
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Avibactam; Ceftazidime; Avibactam, ceftazidime drug combination
• Other Study ID Numbers: IIT20220488A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Respect ethics and protect patient privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No