Status:
NOT_YET_RECRUITING
Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions:
Candidal Peritonitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried...
Detailed Description
Intra-abdominal candidiasis is the most common candidal infection after candididaemia. Studies that have positioned echinocandins as the first therapeutic option in candidiasis have been conducted pri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06985758
Start Date
September 1 2025
End Date
January 1 2026
Last Update
June 22 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
2
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
3
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain, 46010