Study on Optimizing Ceftazidime-Avibactam Dosing for Critically Ill Patients Undergoing Continuous Renal Replacement Therapy

3 1 1 1

What is this study about?

This clinical trial is focused on patients who are critically ill and undergoing a treatment called continuous renal replacement therapy (CRRT). This therapy is often used for patients with severe kidney problems. The study is investigating the use of a medication combination called ceftazidime-avibactam. Ceftazidime is an antibiotic that fights bacteria, and avibactam helps ceftazidime work better by preventing bacteria from breaking it down.

The purpose of the study is to develop an optimized dosing regimen of ceftazidime-avibactam for these patients. Participants in the study will receive the medication intravenously, which means it will be given directly into a vein. The study will monitor how the medication is processed in the body and how well it reaches the desired levels to fight infections effectively. This will help in understanding the best way to dose the medication for patients who are receiving CRRT.

The study will take place over a period of time, and researchers will collect information on how the medication behaves in the body, known as pharmacokinetics. This information will be used to create a model that helps determine the best dosing strategy for ceftazidime-avibactam in critically ill patients. The ultimate goal is to ensure that patients receive the most effective treatment possible while minimizing any potential side effects.

1 initiation of treatment

Upon joining the study, the patient will begin receiving treatment with ceftazidime-avibactam. This medication is administered intravenously, meaning it is given directly into a vein.

The treatment is specifically for patients who are critically ill and undergoing a type of dialysis called continuous renal replacement therapy (CRRT).

2 medication administration

The patient will receive a combination of two substances: ceftazidime and avibactam. These are antibiotics used to treat infections.

The exact dosage and frequency of administration will be determined by the medical team based on the patient’s condition and response to treatment.

3 monitoring and data collection

Throughout the trial, the patient’s response to the medication will be closely monitored. This includes measuring how the body absorbs and processes the medication, known as pharmacokinetics.

The goal is to document the exposure levels of the medication in the body and to optimize the dosing regimen for patients receiving CRRT.

4 completion of trial

The trial is expected to continue until June 2026. During this time, data will be collected to develop an optimized dosing regimen for the medication.

The primary focus is on understanding the pharmacokinetic parameters and achieving the desired therapeutic effect of the medication.

Who Can Join the Study?

  • The participant or their legally authorized representative must provide voluntary written informed consent before starting any study-specific procedures. If oral consent is given first, written consent must be obtained within 72 hours.
  • Participants must use highly effective methods of birth control. These methods should have a very low chance of failure (less than 1% per year) when used correctly. Examples include implants, injectables, combined oral contraceptives, certain IUDs, complete sexual abstinence, or having a partner who has had a vasectomy.
  • The participant must be admitted to the ICU ward, which is a special hospital area for critically ill patients.
  • The participant must be 18 years or older.
  • The participant must be receiving treatment with ceftazidime-avibactam and undergoing any form of continuous renal replacement therapy (CRRT). CRRT is a type of dialysis used for patients with severe kidney problems.

Who Cannot Join the Study?

  • Patients who are not critically ill.
  • Patients who are not undergoing continuous renal replacement therapy (CRRT). CRRT is a type of dialysis treatment for people with severe kidney problems.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet other specific health conditions required for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Del Mar Barcelona Spain
Uwehxgb Ucvdpjtumt Hqyyngub Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.12.2024
Spain Spain
Not yet recruiting
01.12.2024
Sweden Sweden
Recruiting
01.12.2024

Trial locations

Investigated drugs:

Ceftazidime-Avibactam is a combination medication used to treat serious bacterial infections. It works by stopping the growth of bacteria. Ceftazidime is an antibiotic that belongs to a class of drugs known as cephalosporins, while avibactam is a beta-lactamase inhibitor that helps ceftazidime work better against certain bacteria. This combination is particularly used in patients who are critically ill and undergoing continuous renal replacement therapy (CRRT), which is a type of dialysis for patients with severe kidney problems.

Investigated diseases:

Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. In advanced stages, kidney function may decline significantly, potentially requiring dialysis or kidney transplantation. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may see a more rapid deterioration.

Trial ID:
2023-505536-35-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • High-Dose Colecalciferol for 28-Day Mortality in Critically Ill Adults with Severe Vitamin D Deficiency

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany
  • Effect of sodium hydrogen carbonate on kidney health in critically ill patients with metabolic acidosis and acute kidney injury

    Recruiting

    3 1 1 1
    Investigated diseases:
    Germany