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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Candidiasis

Treatments

Drug: Anidulafungin, VER002

Study type

Interventional

Funder types

Industry

Identifiers

NCT00041704

VER002-11

A8851004

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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