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| Name | Class |
|---|---|
| Melinta Therapeutics | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezafungin | Drug | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of proven and probable IFIs | Incidence of proven and probable IFIs within 90 days post-transplant | 90 days post-transplant |
| Incidence of proven and probable breakthrough IFI | Incidence of breakthrough IFI while on specific antifungal prophylaxis | While receiving rezafungin, voriconazole, or fluconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Fungal-free survival | Number of participants without fungal infection | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmakokinectics (PK) of rezafungin | Pharmacokinetics of rezafungin while in ICU to assess the PK during the peri-transplant period | Up to 4 weeks post-transplant |
| Stool microbiota composition | Stool microbiota and fecal Candida constituent and susceptibility profile in response to rezafungin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda Silveira | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
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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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000629634 | Rezafungin |
| D015725 | Fluconazole |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Interventional, open-label, single center study with concurrent and historical controls
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| Standard of care antifungal prophylaxis | Drug | 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. |
|
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| 90 days and 6 months post-transplant |
| Graft rejection | Number of participants with liver allograft acute rejection | 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 | 90 days 6 months post-transplant |
| All-cause mortality | Number of participants who die | 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 | 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 | Within 6 months of transplant |
| Within 6 months post-transplant |