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Clinical trial

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

ID
Name
IIT20220488A
Description
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.
Trial arms
Trial start
2022-01-01
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Recruiting
Treatment
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.
Size
30
Primary endpoint
Plasma drug concentrations of ceftazidime avibactam
0 hour, 2 hours, 4 hours, 6 hours, and 8 hours after the first time of drug administration
Plasma drug concentrations of ceftazidime avibactam
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
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Weeks', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-08-01

1 organization

1 product

1 indication

Organization
First Affiliated Hospital of Zhejiang University
Product
Ceftazidime-avibactam
Indication
Sepsis