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Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

Study acronym: REAREZ
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 7 more changesShow less
    • Trial completed
    • Final enrollment: 18 participants (planned 20)
    • Primary completion date changed from estimate of Jul 1, 2026 to Sep 24, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (6)
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: May 1, 2026 to Jul 1, 2026
    • Start date changed from estimate of Sep 1, 2025 to Nov 14, 2025
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. In critically ill patients, drug levels can vary widely due to factors like surgery, inflammation, fluid resuscitation, or extracorporeal support, increasing the risk of underdosing. Rezafungin is a new antifungal agent with a long half-life and broad activity against Candida species, offering potential advantages in this setting. However, there is currently no data on its concentration or effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis. Its long half-life, coupled with repeated pharmacokinetic variations in critical care settings and the risk of insufficient concentrations, may hinder its use in this population.
Trial Details
NCT Number NCT07093203
Lead Sponsor Central Hospital, Nancy, France
Collaborators: Mundipharma Research GmbH & Co KG
Conditions
(from sponsor)		 Intra-Abdominal Infection, Candida, Abdominal Surgery Patients, Critically Ill Intensive Care Unit Patients
Related terms Intraabdominal Infections, Torulopsis
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov