Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called rezafungin for patients who may have an infection in their abdomen caused by a type of fungus called Candida. This type of infection can sometimes occur after surgery or in patients with weakened immune systems. The study aims to see how well rezafungin works in reaching the infection site in the abdomen compared to other similar treatments. Researchers believe that rezafungin might work better because it can reach higher concentrations in the infected areas, which could help fight the infection more effectively.

To participate in this trial, you need to be an adult over the age of 18 who is suspected of having an abdominal infection caused by Candida and has not responded to previous antibiotic treatments. Women of childbearing age must have a negative pregnancy test before starting the study. Participants will receive detailed information about the study and will need to provide written consent. Throughout the trial, they can expect to undergo some visits and procedures as outlined by the study team. This trial is not yet recruiting participants, but it aims to provide valuable information on how to better treat this serious infection.

Gender

ALL

Eligibility criteria

• 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.