Candidiasis, Oral
Conditions
Keywords
Micafungin, Esophageal Candidiasis, Fluconazole
Brief summary
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
Interventions
DRUGMicafungin
IV
DRUGFluconazole
IV
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of esophageal candidiasis confirmed by endoscopy * Negative pregnancy test in females of childbearing potential
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 |
|---|---|
| Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy | End of Therapy |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response at end of therapy of cleared or improved | End of Therapy |
| Mucosal response at end of therapy of cleared or improved | End of Therapy |
Countries
Brazil, Peru, South Africa
Outcome results
None listed