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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Ceftazidime-avibactam – This medication is administered intravenously, typically in a hospital setting, especially for critically ill patients. It is currently being studied in clinical trials to optimize dosing for patients undergoing continuous renal replacement therapy (CRRT). The main therapeutic use of ceftazidime-avibactam is to treat serious bacterial infections, particularly those caused by resistant strains. At the molecular level, ceftazidime works by inhibiting bacterial cell wall synthesis, while avibactam protects ceftazidime from being broken down by certain bacterial enzymes. It is classified as a combination antibiotic, specifically a cephalosporin with a beta-lactamase inhibitor.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505536-35-00Estimated enrolment14 patientsSponsorUZ Leuven

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