The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

Inclusion Criteria: Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole) Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast Exclusion Criteria: Pregnant female Hypersensitivity to anidulafungin or echinocandin therapy Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid Abnormal blood chemistries: Bilirubin >2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 4 times the upper limit of normal Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents Patients taking other systemic antifungal therapies while on this study