Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis

NCT ID: NCT07093203

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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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 the abdominal surgery
* and having abdominal drain for at least 2 days after the surgery

Exclusion Criteria

* death expected within 24h
* decline to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma Research GmbH & Co KG

INDUSTRY

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, France

Site Status

Countries

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France

Central Contacts

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Emmanuel NOVY, MD, PhD

Role: CONTACT

+33 3 83 15 74 37

Facility Contacts

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Viviane MARTIN, PhD

Role: primary

+33 3 83 15 52 85

Other Identifiers

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2024PI230

Identifier Type: -

Identifier Source: org_study_id

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