Overview
Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis
Status:
Completed
Completed
Trial end date:
2004-12-01
2004-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasisPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Astellas Pharma IncTreatments:
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