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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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