The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)
Completed · Phase 2
Conditions studied: Candidiasis
In brief
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.
Key facts
- Study ID
- NCT00041704
- Run by
- Pfizer
- People needed
- 19
- Starts
- 2002-08-01
- Expected to finish
- 2004-08-01
- Last updated by the study team
- 2008-10-20
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Versicor, Inc. — King of Prussia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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