Candidiasis, Oral
Conditions
Keywords
Micafungin, Esophageal Candidiasis, caspofungin
Brief summary
To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis
Interventions
DRUGmicafungin
IV
DRUGcaspofungin
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative incidence of success, defined as complete clearing of esophageal lesions | End of Therapy |
Secondary
| Measure | Time frame |
|---|---|
| Mycological response | End of Therapy |
| Overall therapeutic response | End of Therapy |
| Clinical response | End of Therapy |
Countries
Argentina, Brazil, Peru, South Africa
Outcome results
None listed