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

Last updated on February 22, 2019

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Study Location
Versicor, Inc.
King of Prussia, Pennsylvania, 19406 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00041704
Pfizer
Completed
The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

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