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.
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
death expected within 24h
decline to participate
This is a prospective PK study of critically ill adult patients with proven or suspected intra-abdominal candidiasis who are admitted to the surgical ICU at the university hospital of Nancy (France). Adult critically ill patients with suspected intra-abdominal candidiasis requiring abdominal surgery and administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery, abdominal drain for at least 2 days after the surgery. Intra-abdominal candidiasis is defined following the 2024 consensus of FUNDICU
Cohort
Prospective
Not listed
Peritoneal/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
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
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.
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.
Postoperative Target Attainment in Plasma
Proportion of patients achieving the pharmacodynamic target in plasma, defined as AUC₀-₁₆₈h / MIC \> 40
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Central Hospital, Nancy, France
Lead sponsor
Mundipharma Research GmbH & Co KG
Collaborator
