Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

King of Prussia, Pennsylvania 19406


Purpose:

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.


Criteria:

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


NCT ID:

NCT00041704


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

King of Prussia, Pennsylvania 19406
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.