Mycoses Clinical Trial
Official title:
Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00342589 -
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|
||
| Completed |
NCT02244606 -
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
|
Phase 2 | |
| Completed |
NCT01232504 -
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
|
Phase 4 | |
| Completed |
NCT00177788 -
Voriconazole as Prophylaxis for Liver Transplant Recipients
|
N/A | |
| Completed |
NCT03667690 -
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
|
Phase 3 | |
| Completed |
NCT00001790 -
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
|
Phase 1 | |
| Recruiting |
NCT04157465 -
Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients
|
N/A | |
| Completed |
NCT00890708 -
Therapeutic Drug Monitoring of Voriconazole
|
N/A | |
| Completed |
NCT00001937 -
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
|
Phase 3 | |
| Completed |
NCT00001757 -
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
|
Phase 3 | |
| Recruiting |
NCT01260974 -
Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients
|
Phase 2 | |
| Completed |
NCT00896493 -
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma
|
Phase 2 | |
| Recruiting |
NCT00673348 -
Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations
|
N/A | |
| Recruiting |
NCT04368559 -
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
|
Phase 3 | |
| Completed |
NCT00413218 -
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
|
Phase 3 | |
| Completed |
NCT04265521 -
Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet
|
N/A | |
| Completed |
NCT01254318 -
Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (Study P07501)
|
N/A | |
| Completed |
NCT02733432 -
RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections
|
Phase 2 | |
| Completed |
NCT00005912 -
Voriconazole to Prevent Systemic Fungal Infections in Children
|
Phase 1 | |
| Completed |
NCT02734862 -
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
|
Phase 2 |