Study of Rezafungin Levels in Blood and Abdominal Fluid of Critically Ill Adults Undergoing Surgery for Intra-abdominal Candida Infection

What this Trial Is About

Intra-abdominal candidiasis is a serious infection often seen in critically ill patients, which can lead to high mortality if not promptly treated. This research evaluates rezafungin, a new antifungal drug with a long half-life and broad activity against Candida species, focusing on its concentration and effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis undergoing abdominal surgery. The study addresses challenges like drug resistance, poor penetration into the abdominal cavity, and variable drug levels caused by critical illness factors. The study observes adult critically ill patients suspected of having intra-abdominal candidiasis who are receiving rezafungin as their first-line empirical antifungal treatment just before or within one hour of abdominal surgery. Patients must have an abdominal drain for at least two days post-surgery. Researchers measure rezafungin levels in plasma and peritoneal fluid over specified time periods, including up to 168 hours after administration, to assess drug penetration and target attainment. Participants will undergo monitoring of rezafungin concentration in plasma and peritoneal fluid from the time of drug administration through the post-surgery period. Researchers will evaluate pharmacokinetic and pharmacodynamic outcomes, including the penetration ratio of the drug into peritoneal fluid and its association with survival up to 28 days after treatment. The study runs from November 2025 with follow-up assessments continuing as per the outlined time frames.

Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis