Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intra-Abdominal Infection, Candida, Abdominal Surgery Patients, Critically Ill Intensive Care Unit Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery
Overview
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.
Primary outcome measures
- Peritoneal/Plasma Penetration Ratio of Rezafungin [Time frame: From 0 to 3 hours after rezafungin administration]
Secondary outcome measures (6)
- Plasma Concentration-Time Profile of Rezafungin [Time frame: From 0 to 168 hours after the first rezafungin administration]
- Peritoneal Concentration-Time Profile of Rezafungin [Time frame: From 0 to 48 hours after the first rezafungin administration]
- Target Attainment in Peritoneal Fluid at the Time of Surgery [Time frame: At the time of abdominal surgery (within the first 3 hours after rezafungin administration)]
- Postoperative Target Attainment in Plasma [Time frame: From 0 to 168 hours after the first rezafungin administration]
- Factors Associated with Target Attainment in Peritoneal Fluid [Time frame: From 0 to 48 hours after the first rezafungin administration]
- Association Between Pharmacodynamic Target Attainment and Day-28 In-Hospital Mortality [Time frame: From rezafungin administration to Day 28 post-treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHRU de Nancy — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT07093203 · 2024PI230