REZAFUNGIN ACETATE for Intra-abdominal candidiasis

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Be over 18 years of age."}
• {"criterion_text":"- Understand the purpose of the study and be available to perform the visits and procedures established in the protocol."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients with an abdominal or peritoneal drain with a permeable debit that allows peritoneal samples to be obtained through it."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients who do not present suspicion of intra-abdominal candidiasis or who are receiving antifungal treatment for another reason."}
• {"criterion_text":"- Patients receiving another antifungal drug during rezafungin administration."}

Primary endpoints

• {"endpoint_text":"- Peritoneal diffusion rate of Rezafungin. Ratio of Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid to Cmax, Cmin and Area Under the Rezafungin Curve in blood.","definition_or_measurement_approach":"Measured as the ratio of Cmax, Cmin and AUC of rezafungin in peritoneal fluid relative to blood (PK sampling and calculation of Cmax, Cmin, AUC)."}
• {"endpoint_text":"- Analysis of peritoneal fluid death curves in the samples per patient obtained according to the previous point.","definition_or_measurement_approach":"Analysis of kill (death) curves of peritoneal fluid samples against reference Candida strains per patient; microbiological kill-curve analysis."}

Secondary endpoints

• {"endpoint_text":"- Duration of treatment.","definition_or_measurement_approach":"Recorded duration of rezafungin administration (treatment days)."}
• {"endpoint_text":"- Overall mortality","definition_or_measurement_approach":"All-cause mortality assessed during study period."}
• {"endpoint_text":"- Attributable mortality.","definition_or_measurement_approach":"Mortality attributable to infection assessed by investigator judgment/definitions in protocol."}
• {"endpoint_text":"- Clinical and microbiological cure.","definition_or_measurement_approach":"Assessment of clinical and microbiological response; secondary analysis performed at end of treatment with rezafungin and at end of follow-up."}

Spain

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

13-08-2025

Processing Time Days

20

Number Of Sites

3

Number Of Participants

20

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain