Can a Long-Acting antifungal reach the Belly's hidden infection?
NCT ID NCT06985758
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are studying rezafungin, an antifungal given by IV, in adults with suspected or confirmed Candida peritonitis, a fungal infection inside the abdomen. The trial measures how much drug gets into peritoneal fluid compared with blood levels. Twenty participants receive a first dose of 400 mg followed by weekly 200 mg doses. The goal is to see whether rezafungin reaches the infection site well enough to help treat it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rezafungin, an antifungal drug given intravenously
- What this could lead to
- If rezafungin reaches high enough levels in peritoneal fluid, it could offer a more reliable way to treat Candida infections inside the abdomen.
- What could go wrong
- This is a small, single-arm study of 20 people, so it cannot prove the drug works better than other treatments. It only measures drug levels, not whether patients recover faster.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with suspicion, confirmed or not, of candidiasis peritonitis or intra-abdominal infection by Candida spp. who, after having received information about the design, the purpose of the study, the possible risks that may arise from it and that they can refuse to collaborate at any time, give written consent to participate in the study. * Be over 18 years of age * Understand the purpose of the study and be available to perform the visits and procedures established in the protocol * In women: negative urine pregnancy test performed in the 7 days prior to the start of study treatment in women of childbearing age and if \< 2 years have passed after menopause * Patients with signs of peritonitis or intra-abdominal infection showing refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected. * Patients with abdominal or peritoneal drainage with permeable debit that allows obtaining peritoneal samples through it. Exclusion Criteria: * Patients in whom there is any contraindication for use according to the established in the technical data sheet or known hypersensitivity to rezafungin or who, according to the investigator's criteria, it is not advisable to participate. * Patients who do not present suspicion of intra-abdominal candidiasis infection or who are receiving antifungal treatment for another reason. * Patients receiving another antifungal drug during rezafungin administration.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
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Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034, Spain