Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Echinocandins; Fluconazole; Micafungin

Criteria

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