Overview

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