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NCT Number: NCT05413343

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 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital,College of Medicine,Zhejiang University

Hangzhou, Zhejiang, 310000, China

About this study

The investigators will collect the 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 from the patients receive treatment with CAZ-AVI to detect plasma drug concentrations of CAZ-AVI. 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 CAZ-AVI. According to the outcomes ,the investigators will characterize the population pharmacokinetics (PPK) of CAZ-AVI in critically ill patients and performed pharmacodynamic target attainment analyses to determine optimal dosing regimens for patients with and without continuous renal replacement therapy (CRRT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Plasma drug concentrations of CAZ-AVI

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

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

  2. Plasma drug concentrations of CAZ-AVI

    Time frame: 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

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

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

    Time frame: After obtaining the patient's plasma drug concentration

    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.

Secondary outcomes

  1. Serum albumin

    Time frame: The day of the first time of drug administration

    The level of serum albumin on the day of the first time of drug administration

  2. Serum albumin

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

    The level of serum albumin on the day of the steady state concentration(more than 4 times drug administration) of drug administration

  3. The level of creatinine

    Time frame: The day of the first time of drug administration

    The level of creatinine on the day of the first time of drug administration

  4. The level of creatinine

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

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

  5. The level of glomerular filtration rate

    Time frame: The day of the first time of drug administration

    The level of glomerular filtration rate on the day of the first time of drug administration

  6. The level of glomerular filtration rate

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

    The level of glomerular filtration rate on the day of the steady state concentration (more than 4 times drug administration) of drug administration

  7. Whether received renal replacement therapy

    Time frame: The day of the first time of drug administration

    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).

  8. Whether received renal replacement therapy

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

    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).

  9. Respiratory function

    Time frame: The day of the first time of administration

    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).

  10. Respiratory function

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

    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).

  11. Cardiovascular function

    Time frame: The day of the first time of drug administration

    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).

  12. Cardiovascular function

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

    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).

  13. CRRT treatment dosage

    Time frame: The day of the first time of drug administration

    The specific parameters for patients undergoing CRRT include the type of CRRT machine, treatment modality, treatment method, filter type, treatment duration, pre-dilution volume, post-dilution volume, blood pump flow rate, dialysis pump flow rate, average hourly fluid removal, treatment dose, ultrafiltration rate, and waste fluid volume

  14. CRRT treatment dosage

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

    The specific parameters for patients undergoing CRRT include the type of CRRT machine, treatment modality, treatment method, filter type, treatment duration, pre-dilution volume, post-dilution volume, blood pump flow rate, dialysis pump flow rate, average hourly fluid removal, treatment dose, ultrafiltration rate, and waste fluid volume

  15. microbiological clearance, infection-related mortality

    Time frame: 14 day after the onset of infection

    microbiological clearance, 14 day infection-related mortality,

  16. all-cause mortality

    Time frame: 30 day and 90 day after the onset of infection

    30 day all-cause mortality,90 day all-cause mortality

  17. length of stay

    Time frame: Day 1 is defined as the day of confirmed diagnosis, the duration from confirmed diagnosis to ICU discharge will be measured.

    Post-infection ICU length of stay

  18. length of stay

    Time frame: From ICU admission to ICU discharge will be measured(assessed up to 120 days).

    Total ICU length of stay.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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