Liver Transplant InfectionPhase 3NCT06774144
Rezafungin Prophylaxis in Liver Transplant
A Phase 3 study testing Rezafungin in people with Liver Transplant Infection and Fungal Infection, run by Fernanda P Silveira, MD, MS at 1 site in United States.
Trial summary
This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Infection, Fungal Infection
- What is being tested?
- Rezafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver transplant recipient
- 18 years of age or older
- ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy anastomosis, or peri-operative Candida colonization, recent Candida infection, renal replacement therapy post-transplant, and reoperation within the first 90 days of transplant.
Who cannot join
- Participants who are perceived not to survive past 7 days after transplant
- Participants who elect not to participate in the prospective trial
- Participants who had active candidiasis at the time of transplant
- Participants with a history of allergy to an echinocandin
- Participants who are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection
This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.
Read the detailed description
This is a single arm interventional study of consecutive liver transplant recipients who have consented to this rezafungin prophylaxis study. The outcome will be compared with that of similar group of patients not enrolled in the study and those who underwent liver transplant in the preceding two years (historical controls). Propensity score matching will be used to select retrospective cohort.
There will be 3 groups:
- Study group (prospective intervention cohort): Rezafungin (180 patients)
- Prospective control group (prospective control cohort): Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's tiered antifungal prophylaxis standard of care (20 patients: 10 who receive fluconazole/voriconazole and 10 who do not receive fluconazole/voriconazole)
- Historical control group (retrospective control cohort): Patients at risk for IFI who received fluconazole/voriconazole (tier approach) in the two years preceding this study (180 patients)
- Conditions
- Liver Transplant Infection, Fungal Infection
- Being tested
- Rezafungin, Standard of care antifungal prophylaxis
- Keywords
- rezafungin, liver transplant, prophylaxis
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezafunginDrug
Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.
Standard of care antifungal prophylaxisDrug
Also called Fluconazole, voriconazole, or no prophylaxis
UPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of >40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Intervention Cohort | Experimental | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks Receives: Drug: Rezafungin |
| Prospective Control Cohort | Active comparator | Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant Receives: Drug: Standard of care antifungal prophylaxis |
| Historical Control Group | Active comparator | Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study Receives: Drug: Standard of care antifungal prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of proven and probable IFIs
Incidence of proven and probable IFIs within 90 days post-transplant
Measured: 90 days post-transplant
Incidence of proven and probable breakthrough IFI
Incidence of breakthrough IFI while on specific antifungal prophylaxis
Measured: While receiving rezafungin, voriconazole, or fluconazole
Secondary outcomes (7)
Fungal-free survival
Number of participants without fungal infection
Measured: 90 days and 6 months post-transplant
Fungal colonization
Number of participants with presence or growth of fungi without it causing active infection or disease
Measured: 90 days and 6 months post-transplant
Graft rejection
Number of participants with liver allograft acute rejection
Measured: 90 days and 6 months post-transplant
Graft loss
Number of participants with failure of the liver allograft to function adequately or to remain viable
Measured: 90 days 6 months post-transplant
All-cause mortality
Number of participants who die
Measured: 90 days 6 months post-transplant
Number of participants with premature discontinuation of prophylaxis
Number of patients who experience an adverse event requiring premature discontinuation of antifungal prophylaxis
Measured: 90 days post-transplant
Overall incidence of development of antifungal resistance
Antifungal resistance of breakthrough fungal organisms or fungal organisms recovered within the first 6 months of transplant for patients who received rezafungin
Measured: Within 6 months of transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Oct 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, open-label, single center study with concurrent and historical controls
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernanda P Silveira, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- Melinta Therapeutics
- Responsible party
- Sponsor-investigator, Fernanda P Silveira, MD, MS, University of Pittsburgh
- Investigators
- Fernanda Silveira, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774144
- Sponsor's protocol ID
- STUDY24080165
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data outside of our investigative team and collaborators. Aggregate data will be shared in publications as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection
- ClinicalTrials.gov ID
- NCT06774144
- Acronym / sponsor ID
- STUDY24080165
- Conditions
- Liver Transplant Infection, Fungal Infection
- Keywords
- rezafungin, liver transplant, prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Fernanda P Silveira, MD, MSUniversity, hospital or other
- Collaborators
- Melinta Therapeutics
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.
Detailed description
This is a single arm interventional study of consecutive liver transplant recipients who have consented to this rezafungin prophylaxis study. The outcome will be compared with that of similar group of patients not enrolled in the study and those who underwent liver transplant in the preceding two years (historical controls). Propensity score matching will be used to select retrospective cohort.
There will be 3 groups:
- Study group (prospective intervention cohort): Rezafungin (180 patients)
- Prospective control group (prospective control cohort): Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's tiered antifungal prophylaxis standard of care (20 patients: 10 who receive fluconazole/voriconazole and 10 who do not receive fluconazole/voriconazole)
- Historical control group (retrospective control cohort): Patients at risk for IFI who received fluconazole/voriconazole (tier approach) in the two years preceding this study (180 patients)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional, open-label, single center study with concurrent and historical controls
| Arm | Type | Receives |
|---|---|---|
| Prospective Intervention Cohort | Experimental | Drug: RezafunginRezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks |
| Prospective Control Cohort | Active comparator | Drug: Standard of care antifungal prophylaxisPatients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant |
| Historical Control Group | Active comparator | Drug: Standard of care antifungal prophylaxisPatients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver transplant recipient
- 18 years of age or older
- ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy anastomosis, or peri-operative Candida colonization, recent Candida infection, renal replacement therapy post-transplant, and reoperation within the first 90 days of transplant.
Key exclusion criteria (5 listed)
- Participants who are perceived not to survive past 7 days after transplant
- Participants who elect not to participate in the prospective trial
- Participants who had active candidiasis at the time of transplant
- Participants with a history of allergy to an echinocandin
- Participants who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RezafunginRezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks. | Drug | Prospective Intervention Cohort |
| Standard of care antifungal prophylaxisAlso: Fluconazole, voriconazole, or no prophylaxisUPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of >40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections. | Drug | Historical Control Group, Prospective Control Cohort |
Primary outcome
Incidence of proven and probable IFIs
Time frame: 90 days post-transplant
Incidence of proven and probable IFIs within 90 days post-transplant
Incidence of proven and probable breakthrough IFI
Time frame: While receiving rezafungin, voriconazole, or fluconazole
Incidence of breakthrough IFI while on specific antifungal prophylaxis
7 secondary outcomes
Fungal-free survival
Time frame: 90 days and 6 months post-transplant
Fungal colonization
Time frame: 90 days and 6 months post-transplant
Graft rejection
Time frame: 90 days and 6 months post-transplant
Graft loss
Time frame: 90 days 6 months post-transplant
All-cause mortality
Time frame: 90 days 6 months post-transplant
Number of participants with premature discontinuation of prophylaxis
Time frame: 90 days post-transplant
Overall incidence of development of antifungal resistance
Time frame: Within 6 months of transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data outside of our investigative team and collaborators. Aggregate data will be shared in publications as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernanda Silveira principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rezafungin in people with Liver Transplant Infection and Fungal Infection, run by Fernanda P Silveira, MD, MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of proven and probable IFIs (time frame: 90 days post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.