Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis

To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis

Inclusion Criteria:

• Diagnosis of esophageal candidiasis confirmed by endoscopy
• Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

• Pregnant or nursing
• Evidence of liver disease
• Presence of 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
• Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
• Non-responsive to therapy in any prior systemic antifungal clinical trail
• History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
• History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals