ReSTORE: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection versus Intravenous Caspofungin Followed by Optional Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis
ReSTORE: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection versus Intravenous Caspofungin Followed by Optional Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis
This study will compare the investigational anti-fungal drug, Rezafungin, to a currently approved drug, caspofungin, to treat adults with severe fungal infections.
INCLUSION: 1. Adult age 18 years or older with confirmed diagnosis of candidemia or invasive candidiasis 2. Currently has 1 or more system signs of candidemia or invasive candidiasis EXCLUSION: 1. Any medical conditions that are not allowed by the protocol 2. Any lab values outside of the ranges allowed by the protocol 3. Possible sources of candidemia/invasive candidiasis that cannot be addressed (IV catheter than cannot be removed, or an abscess that cannot be drained)