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NCT Number: NCT07093203

Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

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.

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Key information

Conditions

Intra-abdominal Infection Abdominal Surgery Patients Candida Critically Ill Intensive Care Unit Patients Infections Intraabdominal Infections Torulopsis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • with a suspected intra-abdominal candidiasis requiring abdominal surgery
  • and receiving the administration of rezafungin as first-line empirical antifungal treatment just before or within 1 hour the abdominal surgery
  • and having abdominal drain for at least 2 days after the surgery

Exclusion criteria

  • death expected within 24h
  • decline to participate

Treatment and study plan

Primary outcomes

  1. Peritoneal/Plasma Penetration Ratio of Rezafungin

    Time frame: From 0 to 3 hours after rezafungin administration

    Penetration ratio of rezafungin will be calculated as the ratio of the area under the concentration-time curve from 0 to 3 hours (AUC₀-₃h) in peritoneal fluid compared to plasma in critically ill patients undergoing abdominal surgery for suspected or proven intra-abdominal candidiasis

Secondary outcomes

  1. Plasma Concentration-Time Profile of Rezafungin

    Time frame: From 0 to 168 hours after the first rezafungin administration

    Area under the concentration-time curve (AUC) of rezafungin in plasma will be calculated over three time intervals: AUC₀-₂₄h, AUC₀-₄₈h, and AUC₀-₁₆₈h to describe the evolution of plasma concentrations during treatment

  2. Peritoneal Concentration-Time Profile of Rezafungin

    Time frame: From 0 to 48 hours after the first rezafungin administration

    Area under the concentration-time curve (AUC) of rezafungin in peritoneal fluid will be calculated over two time intervals: AUC₀-₂₄h and AUC₀-₄₈h to describe the evolution of peritoneal concentrations during treatment.

  3. Target Attainment in Peritoneal Fluid at the Time of Surgery

    Time frame: At the time of abdominal surgery (within the first 3 hours after rezafungin administration)

    Proportion of patients achieving the pharmacodynamic target in peritoneal fluid, defined as AUC₀-₃h / MIC > 40, measured at the time of surgery.

  4. Postoperative Target Attainment in Plasma

    Time frame: From 0 to 168 hours after the first rezafungin administration

    Proportion of patients achieving the pharmacodynamic target in plasma, defined as AUC₀-₁₆₈h / MIC > 40

  5. Factors Associated with Target Attainment in Peritoneal Fluid

    Time frame: From 0 to 48 hours after the first rezafungin administration

    Analysis of clinical and biological covariates associated with pharmacokinetic variability and the achievement of pharmacodynamic targets in peritoneal fluid

  6. Association Between Pharmacodynamic Target Attainment and Day-28 In-Hospital Mortality

    Time frame: From rezafungin administration to Day 28 post-treatment

    Comparison of Day-28 in-hospital mortality rates between patients who did and did not achieve pharmacodynamic targets in plasma and/or peritoneal fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel NOVY, MD, PhD

CONTACT

[email protected]

+33 3 83 15 74 37

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Mundipharma Research GmbH & Co KG

Registry information

Official study title

Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery

Acronym: REAREZ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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