Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

NCT07093203 | Recruiting

• 1 other identifier: 2024PI230
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intra-Abdominal Infection; Candida; Abdominal Surgery Patients; Critically Ill Intensive Care Unit Patients

Keywords

candida; intra-abdominal candidiasis; abdominal surgery; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Peritoneal/Plasma Penetration Ratio of Rezafungin

  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

  From 0 to 3 hours after rezafungin administration

Secondary Outcomes (6)

• Plasma Concentration-Time Profile of Rezafungin

  From 0 to 168 hours after the first rezafungin administration

• Peritoneal Concentration-Time Profile of Rezafungin

  From 0 to 48 hours after the first rezafungin administration

• Target Attainment in Peritoneal Fluid at the Time of Surgery

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

• Postoperative Target Attainment in Plasma

  From 0 to 168 hours after the first rezafungin administration

• Factors Associated with Target Attainment in Peritoneal Fluid

  From 0 to 48 hours after the first rezafungin administration

Study Arms (1)

Adult critically ill patients with suspected or confirmed intra-abdominal candidiasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective PK study of critically ill adult patients with proven or suspected intra-abdominal candidiasis who are admitted to the surgical ICU at the university hospital of Nancy (France). Adult critically ill patients with suspected intra-abdominal candidiasis requiring abdominal surgery and administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery, abdominal drain for at least 2 days after the surgery. Intra-abdominal candidiasis is defined following the 2024 consensus of FUNDICU

You may qualify if:

• 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

You may not qualify if:

• death expected within 24h
• decline to participate

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Mundipharma Research GmbH & Co KG: collaborator

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

MeSH Terms

Conditions

Intraabdominal Infections; Torulopsis

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Emmanuel NOVY, MD, PhD

CONTACT

+33 3 83 15 74 37; e.novy@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)