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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Nov 2025 → Dec 2026
See other at-risk trials from Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Nov 2025 to Dec 2026 Show 5 more changesShow less
    • Start date changed from estimate of Sep 2025 to Jan 7, 2026
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study completion pushed from Jan 2026 to Feb 2027
    • Eligibility criteria expanded, about 9 words
    • Site contacts updated at 3 of 3 sites
  2. Minor Site contacts updated at 3 of 3 sitesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06985758
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions
(from sponsor)
Candidal Peritonitis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov