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

NCT ID: NCT00041704

Last Updated: 2008-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2004-08-31

Brief 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.

Conditions

Candidiasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Anidulafungin, VER002

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vicuron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Locations

Versicor, Inc.

King of Prussia, Pennsylvania, United States

Countries

United States

Other Identifiers

A8851004

Identifier Type: -

Identifier Source: secondary_id

VER002-11

Identifier Type: -

Identifier Source: org_study_id