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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413343
• Other study ID #: IIT20220488A
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Juan Hu, Master
• Phone: +86-18758187703
• Email: 15151041[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis

Intervention

Drug:
• Ceftazidime-avibactam
Patients with severe sepsis and treatment with Ceftazidime-Avibactam 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 ceftazidime avibactam.

Locations

Country	Name	City	State
China	The First Affiliated Hospital,College of Medicine,Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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