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Study of Rezafungin in Blood and Peritoneal Fluid for Patients with Suspected Intra-Abdominal Candidiasis

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What is this trial about?

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

This study focuses on patients with Intra-Abdominal Candidiasis, which is a fungal infection that occurs inside the abdomen. The research examines a medication called Rezafungin, which is given through intravenous infusion (delivered directly into a vein). This medicine belongs to a group of drugs used to treat fungal infections.

The study aims to understand how Rezafungin spreads through the body, particularly how it moves between the blood and the fluid in the abdomen. The medication will be given to patients who have signs of infection in their abdomen that hasn't improved with other treatments. Patients will receive the medicine through an infusion into their vein, and samples will be collected from both their blood and abdominal fluid.

During the study, doctors will monitor how well the medication works against common types of fungi, specifically Candida albicans and Candida glabrata. They will also track the patients' recovery and any changes in their condition. The treatment period may last up to 4 weeks, during which various measurements and observations will be made to evaluate the effectiveness of the medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment
You will receive REZZAYO (rezafungin acetate) through an intravenous infusion - a method where medication is given directly into your vein
This treatment is intended for patients with suspected infection in the abdominal cavity caused by Candida (a type of fungus)
Step 2
Sample collection
Medical staff will collect blood samples to measure drug levels in your bloodstream
Samples of fluid will be taken from your abdominal drain to measure drug levels and evaluate how well it fights the infection
Step 3
Monitoring period
Your progress will be tracked throughout the treatment period
Medical staff will monitor for signs of infection clearing
Regular checks will assess your overall health status
Step 4
Treatment evaluation
The medical team will evaluate how well the infection responds to treatment
They will check if the infection has been cleared from your system
Your overall recovery progress will be assessed
Step 5
Study completion
The treatment period will end based on your individual medical needs
A final evaluation will determine if the infection has been successfully treated
The study is expected to run from August 2025 to January 2026

Who can join the trial?

6 criteria

Must provide written consent after receiving information about the study design, purpose, and potential risks, understanding that participation can be refused at any time
Must be over 18 years of age
Must be able to understand the study purpose and be available for all required visits and procedures
For women of childbearing age: must have a negative pregnancy test within 7 days before starting treatment (applies if less than 2 years since menopause)
Must have signs of peritonitis (inflammation of the tissue that lines the inner wall of the abdomen) or intra-abdominal infection that has not responded to at least 48 hours of antibiotic treatment, with suspected candida infection
Must have a working abdominal or peritoneal drain (a tube placed in the abdomen) that allows collection of peritoneal fluid samples

Who cannot join the trial?

15 criteria

Known allergy or severe reaction to rezafungin or similar antifungal medications
Pregnant or breastfeeding women
Severe liver problems (as measured by liver function tests)
Severe kidney problems (as shown by kidney function tests)
Current participation in other clinical trials
History of significant heart problems or irregular heart rhythm
Active cancer treatment
Severe immune system disorders
History of organ transplantation
Inability to provide informed consent
Severe blood disorders
Taking medications that could interact with rezafungin
History of alcohol or drug abuse within the past 6 months
Mental conditions that could affect study participation
Unstable medical condition that could interfere with study procedures

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Rezafungin is an antifungal medication used to treat serious fungal infections, particularly those caused by Candida species. It works by targeting and destroying fungal cells that can cause infections in the abdominal cavity. This medication is specifically being studied for its effectiveness in treating intra-abdominal candidiasis, which is a fungal infection within the abdomen. The medication is being evaluated for how well it spreads into the peritoneal fluid (fluid in the abdominal cavity) and how effectively it can kill different types of Candida fungi.

Rezafungin Acetate

What is already known about the treatment

Rezafungin - An antifungal medication administered intravenously that is being studied for the treatment of intra-abdominal candidiasis, a serious fungal infection in the abdominal cavity. This novel echinocandin class drug works by inhibiting the synthesis of beta-1,3-D-glucan, an essential component of fungal cell walls, leading to cell death of Candida species including C. albicans and C. glabrata. The medication is currently undergoing clinical trials to evaluate its effectiveness in treating invasive fungal infections, with particular focus on its ability to penetrate peritoneal fluid and its candicidal (fungus-killing) activity in the abdominal cavity.

Investigated diseases

Intra-Abdominal Candidiasis - A fungal infection that occurs within the abdominal cavity, caused by various species of Candida fungi, particularly Candida albicans and Candida glabrata. The infection develops when Candida spreads into the abdominal space, potentially affecting organs and tissues within this area. The condition can occur following abdominal surgery, in patients with compromised immune systems, or due to other underlying medical conditions. Symptoms typically include abdominal pain, fever, and general discomfort in the abdominal region. The infection can spread through the peritoneal fluid, which is the fluid within the abdominal cavity.