None listed
Conditions
Interventions
Medication: micafungin Type of group
Daily dose of micafungin is administered
Group name:Medication: micafungin Type of group
Micafungin is administered in doses on alternate days, alternating with placebo.
Sponsors
FUJISAWA HEALTH CARE INC,
Eligibility
Inclusion criteria
Inclusion criteria: Esophageal candidiasis confirmed by endoscopy Negative pregnancy test for female patients of childbearing potential
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:complete clearing of esophageal lesions Measure: Comparative incidence of success, defined as complete clearing of esophageal lesions Timepoints:End of Therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Overall therapeutic response Measure:Overall therapeutic response Timepoints:End of Therapy | — |
Countries
Argentina, Brazil, Peru, South Africa
Outcome results
None listed