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

Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041704
• Other study ID #: VER002-11
• Secondary ID: A8851004
• Status: Completed
• Phase: Phase 2
• First received: July 12, 2002
• Last updated: October 17, 2008
• Start date: August 2002
• Est. completion date: August 2004

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Candidiasis

Intervention

Drug:
• Anidulafungin, VER002

Locations

Country	Name	City	State
United States	Versicor, Inc.	King of Prussia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States,