Rezafungin levels in the abdominal fluid for intra-abdominal Candida infections
Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery
This will test whether the antifungal rezafungin reaches effective levels in the abdominal (peritoneal) fluid of adults having surgery for suspected intra-abdominal Candida infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy, Lorraine) |
| Trial ID | NCT07093203 on ClinicalTrials.gov |
What this trial studies
This observational study will measure rezafungin concentrations in both plasma and peritoneal (abdominal) fluid in adults undergoing surgery for suspected intra-abdominal candidiasis. Participants receive rezafungin as first-line empirical antifungal therapy just before or within one hour of surgery, and peritoneal samples are collected from abdominal drains for at least two days. Pharmacokinetic and pharmacodynamic analyses will compare peritoneal levels with plasma levels and known therapeutic targets to determine whether adequate drug exposure is achieved in the abdominal cavity. No experimental interventions beyond standard clinical care are required; the primary output is concentration and diffusion data to inform dosing decisions in critically ill surgical patients.
Who should consider this trial
Good fit: Adults (age ≥18) undergoing abdominal surgery for suspected intra-abdominal candidiasis who are given rezafungin as first-line empirical antifungal therapy and who will have an abdominal drain for at least two days are eligible.
Not a fit: Patients expected to die within 24 hours, those who decline participation, or patients who do not receive rezafungin or lack a peritoneal drain would not benefit from or contribute to this study's findings.
Why it matters
Potential benefit: If successful, the results could show whether rezafungin reaches therapeutic concentrations in the peritoneal cavity and help guide dosing for adults with intra-abdominal Candida infections.
How similar studies have performed: Rezafungin has shown favorable systemic pharmacokinetics and broad activity against Candida in prior studies, but peritoneal fluid penetration in intra-abdominal infection has not been previously characterized.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vandœuvre-lès-Nancy, Lorraine
- CHRU de Nancy — Vandœuvre-lès-Nancy, Lorraine, France (Recruiting)
Study contacts
- Study coordinator: Emmanuel NOVY, MD, PhD
- Email: e.novy@chru-nancy.fr
- Phone: +33 3 83 15 74 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.