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)