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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHRU de Nancy
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Emmanuel NOVY, MD, PhD
e.novy@chru-nancy.fr
+33 3 83 15 74 37
Time Frame
Start Date: 2025-11-14
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 20
Treatments
Adult critically ill patients with suspected or confirmed intra-abdominal candidiasis
Related Therapeutic Areas
Sponsors
Collaborators: Mundipharma Research GmbH & Co KG
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov