Trials / Recruiting
RecruitingNCT07093203
Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2025-11-14
- Primary completion
- 2026-07-01
- Completion
- 2026-09-01
- First posted
- 2025-07-30
- Last updated
- 2026-04-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07093203. Inclusion in this directory is not an endorsement.