Actively Recruiting

Age: 18Years +
All Genders
NCT07093203

Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

Led by Central Hospital, Nancy, France · Updated on 2026-04-01

20

Participants Needed

1

Research Sites

41 weeks

Total Duration

On this page

Sponsors

C

Central Hospital, Nancy, France

Lead Sponsor

M

Mundipharma Research GmbH & Co KG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Suspected intra-abdominal candidiasis requiring abdominal surgery
  • Receiving rezafungin as first-line empirical antifungal treatment just before or within 1 hour of abdominal surgery
  • Having an abdominal drain for at least 2 days after surgery
Not Eligible

You will not qualify if you...

  • Death expected within 24 hours
  • Decline to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, France, 54500

Actively Recruiting

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Research Team

E

Emmanuel NOVY, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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