RecruitingRare disease

Study on Rezafungin Levels in Critically Ill Patients with Invasive Candidiasis Undergoing ECMO or RRT

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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 studying a serious fungal infection known as invasive candidiasis. This condition can occur in critically ill patients, particularly those receiving advanced medical support like extracorporeal membrane oxygenation (ECMO) or renal replacement therapy (RRT). The treatment being investigated is a medication called Rezafungin, which is part of a group of antifungal medicines known as echinocandins. Rezafungin is administered as a solution through an intravenous infusion, meaning it is given directly into the bloodstream.

The purpose of this study is to evaluate how Rezafungin behaves in the body of patients who are receiving ECMO, with or without RRT. This includes understanding how the drug is absorbed, distributed, and eliminated from the body. The study will monitor the levels of Rezafungin in the blood to gather this information. Patients participating in the study will receive Rezafungin as part of their treatment for invasive candidiasis, and their response to the medication will be closely observed.

Throughout the study, researchers will also look at how different factors, such as additional medical treatments, body weight, and gender, might affect the levels of Rezafungin in the blood. Additionally, any side effects experienced by patients will be recorded, as well as any reasons for stopping the treatment. The study aims to provide valuable insights into the use of Rezafungin in critically ill patients, helping to improve treatment strategies for those with invasive candidiasis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, ensure that you have provided prior written informed consent. If you are conscious, this consent is obtained before participation. If you are unconscious, consent will be obtained after you regain consciousness.
Step 2
Receiving treatment
You will receive a medication called Rezafungin, which is used to treat invasive fungal infections. This medication is administered as a solution for infusion, meaning it is given directly into your bloodstream through a vein.
The dosage of Rezafungin is 200 mg, and it is given intravenously. The frequency and duration of administration will be determined by the medical team based on your specific condition and response to treatment.
Step 3
Monitoring and assessments
Throughout the trial, your plasma concentrations of Rezafungin will be monitored. This involves taking blood samples to measure how much of the medication is in your bloodstream at various times.
The trial aims to evaluate several factors, including how your body processes the medication, such as its clearance, volume of distribution, and half-life. These assessments help understand the medication's effectiveness and safety.
Step 4
Additional evaluations
The trial will also assess differences in Rezafungin plasma concentration based on additional treatments you may be receiving, such as extracorporeal circuits like RRT (renal replacement therapy) or hemoperfusion.
Other factors, such as your body-mass index and gender, will be considered to understand how they might affect the medication's concentration in your body.
Step 5
Monitoring side effects
The medical team will monitor for any side effects you may experience from the Rezafungin treatment. Side effects are any unwanted or unexpected symptoms or feelings that occur during the trial.
If you experience any side effects, the medical team will determine the appropriate course of action, which may include adjusting the treatment or discontinuing it if necessary.
Step 6
Completion of the trial
The trial is estimated to end by April 1, 2028. Your participation will continue until the trial's conclusion or until the medical team decides it is appropriate for you to stop.
Upon completion, the results will contribute to understanding the effectiveness and safety of Rezafungin in patients receiving extracorporeal treatments.

Who can join the trial?

5 criteria

Must be an ICU patient (a patient in the Intensive Care Unit).
Must be 18 years of age or older.
Must be receiving ECMO support (a machine that helps with breathing and heart function) with or without RRT (a treatment that helps the kidneys).
Must be receiving Rezafungin (a medication for fungal infections).
Must provide written informed consent (agreement to participate after understanding the study). If the patient is unconscious, consent will be obtained after they wake up.

Who cannot join the trial?

7 criteria

Patients who do not have invasive candidiasis cannot participate. Invasive candidiasis is a serious infection caused by a type of yeast (fungus) that can enter the bloodstream and spread to other parts of the body.
Patients who are not receiving extracorporeal membrane oxygenation (ECMO) cannot participate. ECMO is a treatment that uses a machine to take over the work of the lungs and sometimes the heart.
Patients who are not receiving renal replacement therapy (RRT) cannot participate. RRT is a treatment that replaces the normal blood-filtering function of the kidneys.
Patients who are not critically ill cannot participate. Critically ill means being very sick and needing intensive medical care.
Patients who are not within the specified age range cannot participate. The age range includes young adults and older adults.
Both male and female patients can participate, but those who do not identify as either cannot participate.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may be at a higher risk of harm or exploitation.

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Medical University Of Graz
Graz, Austria

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Investigated drugs

Rezafungin is a medication used to treat serious fungal infections. It works by stopping the growth of fungi, which helps to clear the infection from the body. In this clinical trial, Rezafungin is being studied to see how it behaves in the blood of patients who are critically ill and receiving special treatments like ECMO, which is a machine that helps with breathing and circulation, and possibly RRT, which is a treatment that helps the kidneys. The goal is to understand how much of the medication stays in the blood during these treatments, which can help doctors know how to use it more effectively in the future for patients with similar conditions.

Rezafungin Acetate

What is already known about the treatment

Rezafungin – Rezafungin is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials, particularly for its effectiveness in patients undergoing extracorporeal treatments like ECMO (extracorporeal membrane oxygenation) with or without RRT (renal replacement therapy). The main use of Rezafungin is to treat invasive candidiasis, a serious fungal infection. At the molecular level, Rezafungin works by inhibiting the synthesis of a key component of the fungal cell wall, which ultimately leads to the death of the fungus. It belongs to a class of drugs known as echinocandins, which are antifungal agents.

Investigated diseases

Invasive candidiasis – Invasive candidiasis is a serious fungal infection caused by Candida species, which can enter the bloodstream and spread throughout the body. This condition often affects individuals with weakened immune systems or those undergoing medical treatments such as surgery or catheterization. The infection can lead to complications in various organs, including the heart, brain, eyes, and bones. It typically begins with symptoms like fever and chills that do not improve with antibiotic treatment. As the infection progresses, it can cause organ dysfunction and systemic symptoms. The disease requires careful monitoring and management to prevent further complications.