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

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What is this study about?

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.

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)

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.08.2025

Trial locations

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.

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.

Trial ID:
2025-521854-40-00
Protocol code:
REZAPACQ
Trial Phase:
Therapeutic confirmatory (Phase III)

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