In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for invasive Candida infection. This trial is being conducted in Austria and focuses on evaluating the antifungal medication Rezafungin in critically ill patients who require advanced life support systems such as extracorporeal membrane oxygenation (ECMO) or renal replacement therapy (RRT). The study aims to understand how this medication behaves in the body under these challenging medical conditions.
Clinical trial locations
Study on Rezafungin Levels in Critically Ill Patients with Invasive Candidiasis Undergoing ECMO or RRT
This clinical trial is investigating invasive candidiasis, a serious fungal infection that can occur in critically ill patients. The condition is caused by Candida species and can spread through the bloodstream to affect multiple organs including the heart, brain, eyes, and bones. Patients who are particularly vulnerable include those with weakened immune systems or those receiving intensive medical support.
Who can participate:
The trial is open to adults aged 18 years and older who are being treated in an Intensive Care Unit (ICU). To be eligible, patients must be receiving ECMO support, which is a machine that helps with breathing and heart function, with or without RRT, a treatment that assists the kidneys. Participants must also be receiving treatment with Rezafungin for their fungal infection. Written informed consent is required before joining the study. If a patient is unconscious at the time of enrollment, consent will be obtained once they regain consciousness.
Who cannot participate:
Patients who do not have invasive candidiasis are not eligible for this study. Additionally, those who are not receiving ECMO or RRT, or who are not critically ill, cannot participate. The trial is designed specifically for patients requiring these advanced medical interventions.
What the trial aims to achieve:
The main goal of this study is to understand how Rezafungin behaves in the body of critically ill patients receiving ECMO, with or without RRT. Researchers will monitor the levels of the medication in the blood to see how it is absorbed, distributed, and eliminated. The study will also examine how various factors such as body weight, gender, and additional medical treatments might affect drug levels. Throughout the trial, any side effects experienced by patients will be carefully recorded and monitored.
The investigational drug:
Rezafungin is an antifungal medication belonging to a class of drugs called echinocandins. It works by stopping the growth of fungi, specifically by inhibiting the production of a key component of the fungal cell wall, which leads to the death of the fungus. In this trial, Rezafungin is given as a 200 mg dose directly into the bloodstream through an intravenous infusion. The medication is being studied to help doctors understand how to use it more effectively in patients with invasive candidiasis who require complex life support systems. Blood samples will be taken at various times to measure how much medication is present in the bloodstream, helping researchers determine the optimal dosing strategy for this patient population.
The trial is expected to continue until April 2028 and will provide valuable information about using Rezafungin in one of the most challenging patient populations.
Summary
Currently, there is only one clinical trial available for patients with invasive Candida infection. This trial is being conducted exclusively in Austria and focuses on a specific subset of patients: those who are critically ill and require advanced life support through ECMO or RRT. The study concentrates on a single antifungal medication, Rezafungin, which belongs to the echinocandin class of drugs. The trial's specific focus on patients receiving extracorporeal support reflects the unique challenges in treating fungal infections in this vulnerable population, where understanding medication behavior is crucial for effective treatment. Patients interested in participating should discuss eligibility with their medical team, as the trial has specific requirements related to ICU admission and the use of ECMO or RRT.
