NCT07093203 Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
| NCT ID | NCT07093203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | Intra-Abdominal Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-11-14 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07093203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intra-Abdominal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07093203 currently recruiting?
Yes, NCT07093203 is actively recruiting participants. Contact the research team at e.novy@chru-nancy.fr for enrollment information.
Where is the NCT07093203 trial being conducted?
This trial is being conducted at Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT07093203 clinical trial?
NCT07093203 is sponsored by Central Hospital, Nancy, France. The trial plans to enroll 20 participants.