Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis

To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Inclusion Criteria:

• Esophageal candidiasis confirmed by endoscopy
• Negative pregnancy test for female patients of childbearing potential

Exclusion Criteria:

• Pregnant or nursing female patient
• Evidence of liver disease
• Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
• Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
• Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
• Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
• Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
• History of anaphylaxis attributed to echinocandin class of antifungals