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Pharmacokinetic Study of Rezafungin in Patients with Suspected Intra-Abdominal Candidiasis: Peritoneal Diffusion and Candicidal Activity
EU CTIS ID: 2025-521854-40-00
What this study is testing
To analyse the following PK parameters: Cmax, Cmin and area under the curve of rezafungin in blood and peritoneal fluid in patients with suspected intra-abdominal candidiasis. To evaluate the Candicidal activity of peritoneal fluid against two reference strains of Candida albicans and Candida glabrata, using kill curves.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with confirmed or unconfirmed suspicion of candidal peritonitis or intra-abdominal Candida spp. infection who, after receiving information about the study design, the purpose of the study, the potential risks involved and that they may refuse to participate 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 within 7 days prior to the start of study treatment in women of childbearing age and if < 2 years have passed since menopause.
- Patients with signs of peritonitis or intra-abdominal infection who show refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected.
- Patients with an abdominal or peritoneal drain with a permeable debit that allows peritoneal samples to be obtained through it.
You likely can't join if
- Patients in whom there is a contraindication for use in accordance with the terms of the technical data sheet or known hypersensitivity to rezafungin or whose participation is not advisable in the opinion of the investigator.
- Patients who do not present suspicion of intra-abdominal candidiasis or who are receiving antifungal treatment for another reason.
- Patients receiving another antifungal drug during rezafungin administration.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.