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

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 out mainly in patients with candidemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level in relation to isolates at the blood culture level. Rezafungin, with its special pharmacokinetics, achieves higher tissue concentrations, including hepato-splenic and other abdominal organs, than the other echinocandins. Experimental studies have confirmed that the concentration of rezafungin at the level of the inflammatory focus in abdominal infections is higher than in the surrounding healthy tissue and higher than those achieved by micafungin. Finally, the biofilm activity of rezafungin is very high, clearly superior to fluconazole and possibly higher than that of other echinocandins.

NCT Number	NCT06985758
Lead Sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions	Candidal Peritonitis
Enrollment	20 participants
Start Date	2025-09
Primary Completion	2025-11 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-22