Rezafungin acetate for Invasive candidiasis | Candidemia

Inclusion criteria

• {"criterion_text":"- ICU patient with ≥18 years of age"}
• {"criterion_text":"- ECMO support (iLA active or others) or Critically ill patients receiving Rezafungin for treatment of invasive fungal infection without extracorporeal treatments will be recruited by study team members and data will be used for comparative analysis ± RRT"}
• {"criterion_text":"- Rezafungin administration"}
• {"criterion_text":"- Prior written informed consent (IC) in counscious patients; in inconscious patients the IC will be obtained after arousal."}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to Rezafungin or other echinocandins"}
• {"criterion_text":"- Pregnant or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Clearance (CL)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Volume of Distribution (Vd)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Half-Life (t½)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Absorption Rate Constant (Ka)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Bioavailability (F)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Maximum Concentration (Cmax)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Time to Maximum Concentration (Tmax)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Area Under the Curve (AUC)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}
• {"endpoint_text":"- Elimination Rate Constant (Ke)","definition_or_measurement_approach":"Assessment of Rezafungin plasma concentrations (pharmacokinetic analysis)"}

Secondary endpoints

• {"endpoint_text":"- Difference in Rezafunding plasma concentration according to additional extracorporal circuits (RRT, Hemoperfusion)","definition_or_measurement_approach":"Comparison of Rezafungin plasma concentrations between subgroups with different extracorporeal circuits (pharmacokinetic subgroup analysis)"}
• {"endpoint_text":"- Difference of Rezafunding plasma concentration according to body-mass index and gender","definition_or_measurement_approach":"Comparison of Rezafungin plasma concentrations by BMI and sex (pharmacokinetic subgroup analysis)"}
• {"endpoint_text":"- Side effects of Rezafungin treatment (As defined by the treating physician)","definition_or_measurement_approach":"Recording and reporting of adverse events/side effects as assessed by treating physicians"}
• {"endpoint_text":"- Rate of Rezafungin discontinuation and reasons for cessation","definition_or_measurement_approach":"Collection of treatment discontinuation events and documented reasons"}

Methods

• Site-based recruitment: critically ill patients receiving Rezafungin and ECMO patients will be recruited by study team members at participating sites (Austria site listed).

Austria

Earliest CTIS Part Ii Submission Date

26-02-2025

Latest Decision Or Authorization Date

26-01-2026

Processing Time Days

334

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"Mundipharma GmbH","duties_or_roles":"Monetary support","organisation_type":""}