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The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients
A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.
Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.
Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.
Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.
The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anidulafungin | Experimental | anti-fungal agent |
|
| Fluconazole | Active Comparator | anti-fungal agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anidulafungin | Drug | 200 mg IV loading dose followed by 100 mg qd for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Fungal Infection | 90 days post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Additional Antifungal Therapy | 90 days post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Singh, MD | University of Pittaburgh, VA Pittsburgh Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Cente | Los Angeles | California | 90095 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25376267 | Result | Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Singh N. Randomized, double-blind trial of anidulafungin versus fluconazole for prophylaxis of invasive fungal infections in high-risk liver transplant recipients. Am J Transplant. 2014 Dec;14(12):2758-64. doi: 10.1111/ajt.12963. Epub 2014 Nov 6. | |
| 26050015 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin | anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days |
| FG001 | Fluconazole | anti-fungal agent Fluconazole: 400 mg IV for 21 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluconazole | Drug | 400 mg IV for 21 days |
|
|
| Miami |
| Florida |
| 33136 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Singh N, Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Wagener MM, Wheat LJ. Performance Characteristics of Galactomannan and beta-d-Glucan in High-Risk Liver Transplant Recipients. Transplantation. 2015 Dec;99(12):2543-50. doi: 10.1097/TP.0000000000000763. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin | anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days |
| BG001 | Fluconazole | anti-fungal agent Fluconazole: 400 mg IV for 21 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Fungal Infection | Posted | Number | participants | 90 days post enrollment |
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| Secondary | Need for Additional Antifungal Therapy | Posted | Number | participants | 90 days post enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anidulafungin | anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days | 1 | 98 | 11 | 98 | ||
| EG001 | Fluconazole | anti-fungal agent Fluconazole: 400 mg IV for 21 days | 0 | 99 | 11 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged QT interval | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| deaths | General disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nina Singh | University of Pittsburgh | 412 360-1688 | nis5@pitt.edu |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D016469 | Fungemia |
| D020314 | Central Nervous System Fungal Infections |
| D008172 | Lung Diseases, Fungal |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077612 | Anidulafungin |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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|