Overview
Sponsor-declared trial summary
Invasive candidiasis
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.
Key facts
- Sponsor
- Medical University Of Graz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 16 Apr 2025 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Mundipharma GmbH
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Pharmacokinetic, Dose response, Efficacy
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.
Secondary objectives 1
- Evaluate differences of Rezafungin plasma concentration in subgroups and evaluate potential side effects.
Conditions and MedDRA coding
Invasive candidiasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10060573 | Candidemia | 10021881 |
| 20.1 | LLT | 10007152 | Candidiasis | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- ICU patient with ≥18 years of age
- 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
- Rezafungin administration
- Prior written informed consent (IC) in counscious patients; in inconscious patients the IC will be obtained after arousal.
Exclusion criteria 2
- Known hypersensitivity to Rezafungin or other echinocandins
- Pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 9
- Clearance (CL)
- Volume of Distribution (Vd)
- Half-Life (t½)
- Absorption Rate Constant (Ka)
- Bioavailability (F)
- Maximum Concentration (Cmax)
- Time to Maximum Concentration (Tmax)
- Area Under the Curve (AUC)
- Elimination Rate Constant (Ke)
Secondary endpoints 4
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
REZZAYO 200 mg powder for concentrate for solution for infusion
PRD11067940 · Product
- Active substance
- Rezafungin Acetate
- Substance synonyms
- CD101 ACETATE
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX — OTHER ANTIMYCOTICS FOR SYSTEMIC USE
- Marketing authorisation
- EU/1/23/1775/001
- MA holder
- MUNDIPHARMA GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2385
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Graz
- Sponsor organisation
- Medical University Of Graz
- Address
- Neue Stiftingtalstrasse 6
- City
- Graz
- Postcode
- 8010
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Graz
- Contact name
- Coordination center for Clinical Trials
Public contact point
- Organisation
- Medical University Of Graz
- Contact name
- Coordination center for Clinical Trials
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-04-16 | 2025-06-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519789-37-00_redacted | 3.0 |
| Protocol (for publication) | D1_Protocol 2024-519789-37-00_V2_TC_redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF capable subjects_V1_TC_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF incapacitated subjects_V1_TC_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal designated representative_V1_TC_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ incapacitated subjects_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_capable subjects_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_legal designated representative_redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rezzayo | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE 2024-519789-37-00 | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-19 | Austria | Acceptable 2025-04-07
|
2025-04-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-28 | Austria | Acceptable 2025-12-29
|
2026-01-26 |