None listed
Conditions
Interventions
50 mg of lyophilized micatungin (FK463) will be administered.
Group name:fluconazole 200 mg Type of group
fluconazole 200 mg will be given intravenously once a day.
Sponsors
FUJISAWA HEALTH CARE INC,
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of esophageal candidiasis confirmed by endoscopy Negative pregnancy test in females of childbearing potential
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Endoscopic cure Measure:Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy Timepoints:End of Therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical analysis Measure:Clinical response at end of therapy of cleared or improved Timepoints:End of Therapy | — |
Countries
Canada, Peru, United Kindgdom, United States
Outcome results
None listed