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.
Study Type
OBSERVATIONAL
Enrollment
20
CHRU de Nancy
Vandœuvre-lès-Nancy, Lorraine, France
RECRUITINGPeritoneal/Plasma Penetration Ratio of Rezafungin
Penetration ratio of rezafungin will be calculated as the ratio of the area under the concentration-time curve from 0 to 3 hours (AUC₀-₃h) in peritoneal fluid compared to plasma in critically ill patients undergoing abdominal surgery for suspected or proven intra-abdominal candidiasis
Time frame: From 0 to 3 hours after rezafungin administration
Plasma Concentration-Time Profile of Rezafungin
Area under the concentration-time curve (AUC) of rezafungin in plasma will be calculated over three time intervals: AUC₀-₂₄h, AUC₀-₄₈h, and AUC₀-₁₆₈h to describe the evolution of plasma concentrations during treatment
Time frame: From 0 to 168 hours after the first rezafungin administration
Peritoneal Concentration-Time Profile of Rezafungin
Area under the concentration-time curve (AUC) of rezafungin in peritoneal fluid will be calculated over two time intervals: AUC₀-₂₄h and AUC₀-₄₈h to describe the evolution of peritoneal concentrations during treatment.
Time frame: From 0 to 48 hours after the first rezafungin administration
Target Attainment in Peritoneal Fluid at the Time of Surgery
Proportion of patients achieving the pharmacodynamic target in peritoneal fluid, defined as AUC₀-₃h / MIC \> 40, measured 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
Proportion of patients achieving the pharmacodynamic target in plasma, defined as AUC₀-₁₆₈h / MIC \> 40
Time frame: From 0 to 168 hours after the first rezafungin administration
Factors Associated with Target Attainment in Peritoneal Fluid
Analysis of clinical and biological covariates associated with pharmacokinetic variability and the achievement of pharmacodynamic targets 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
Comparison of Day-28 in-hospital mortality rates between patients who did and did not achieve pharmacodynamic targets in plasma and/or peritoneal fluid
Time frame: From rezafungin administration to Day 28 post-treatment
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