2024-519789-37-00RecruitingPhase 4
Rezafungin plasma concentrations in patients receiving extracorporal treatments (ECMO ± RRT) (REZAFECT)
Medical University Of Graz1 site in 1 country15 target enrollmentStarted: April 14, 2025Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Clearance (CL)
Study Overview
Brief Summary
To evaluate Rezafungin plasma concentrations in patients with ECMO (with or without RRT) receiving Rezafungin for treatment of invasive fungal infection in critically ill patients with extracorporeal treatments.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ICU patient with ≥18 years of age
- •ECMO support (iLA active or others) ± RRT
- •Rezafungin administration
- •Prior written informed consent (IC) in counscious patients; in inconscious patients the IC will be obtained after arousal.
Exclusion Criteria
- •Known hypersensitivity to Rezafungin or other echinocandins
- •Pregnant or breastfeeding
Outcomes
Primary Outcomes
Clearance (CL)
Clearance (CL)
Volume of Distribution (Vd)
Volume of Distribution (Vd)
Half-Life (t½)
Half-Life (t½)
Absorption Rate Constant (Ka)
Absorption Rate Constant (Ka)
Maximum Concentration (Cmax)
Maximum Concentration (Cmax)
Bioavailability (F)
Bioavailability (F)
Time to Maximum Concentration (Tmax)
Time to Maximum Concentration (Tmax)
Area Under the Curve (AUC)
Area Under the Curve (AUC)
Elimination Rate Constant (Ke)
Elimination Rate Constant (Ke)
Secondary Outcomes
- Difference in Rezafunding plasma concentration according to additional extracorporal circuits (RRT, Hemoperfusion)
- Difference of Rezafunding plasma concentration according to body-mass index and gender
- Side effects of Rezafungin treatment (As defined by the treating physician)
- Rate of Rezafungin discontinuation and reasons for cessation
Investigators
Coordination center for Clinical Trials
Scientific
Medical University Of Graz
Study Sites (1)
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