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A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO) (MARIO)
Rochester, Minn.
The purpose of this study is to demonstrate that treatment of Invasive Candidiasis/ Candidemia with intravenous (IV) echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on 30-day all-cause mortality (ACM).
Furthermore, to demonstrate that treatment of Invasive Candidiasis/ Candidemia with IV echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on Global Response (clinical, radiological, and mycological response, as confirmed by the Data Review Committee [DRC]) at Day 14
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A Phase 3, Multicenter, Prospective, Randomized, Double-blind, Efficacy and Safety Study of Rezafungin for Injection Versus the Standard Antimicrobial Regimen for the Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)
Rochester, Minn.
The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).
The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).
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A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis (ReSTORE)
Rochester, Minn.
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
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Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI) (FURI)
Rochester, Minn.
The purpose of this study is to see how well study drug works at treating people with fungal diseases that are refractory to or intolerant of Standard Antifungal Treatment.
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The Role of Interferon-gamma in Antifungal Immunity (IFN)
Rochester, Minn.
The purpose of this study is to evaluate the role of interferon-gamma (IFN-γ) in antifungal defense and its potential use in adjunctive immunotherapy. Solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients are at increased risk for invasive fungal infections. Mortality rates remain unacceptably high despite antifungal treatment. Novel therapeutic modalities are urgently needed. In this project, we propose to study the role of interferon-gamma (IFN-gamma) in antifungal defense and its potential use in adjunctive immunotherapy.
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