Candidiasis
Conditions
Keywords
Azole-Refractory Mucosal Candidiasis, Mucosal Candidiasis
Brief summary
Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.
Interventions
Sponsors
Vicuron Pharmaceuticals
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed