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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis

Intervention: Anidulafungin, VER002 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

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.

Clinical Details

Official title: A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Versicor, Inc., King of Prussia, Pennsylvania 19406, United States
Additional Information

Starting date: August 2002
Last updated: October 17, 2008

Page last updated: August 20, 2015

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