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

This study has been completed.

First Received on July 12, 2002. Last Updated on October 17, 2008 History of Changes

Sponsor:	Pfizer
Collaborator:	Vicuron Pharmaceuticals
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00041704

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.

Condition	Intervention	Phase
Candidiasis	Drug: Anidulafungin, VER002	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Anidulafungin

U.S. FDA Resources

Further study details as provided by Pfizer:

Enrollment:	19
Study Start Date:	August 2002
Study Completion Date:	August 2004

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041704

Locations

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

Sponsors and Collaborators

Pfizer

Vicuron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00041704 History of Changes
Other Study ID Numbers:	VER002-11, A8851004
Study First Received:	July 12, 2002
Last Updated:	October 17, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Azole-Refractory Mucosal Candidiasis
Mucosal Candidiasis

Additional relevant MeSH terms:

Candidiasis
Mycoses
Anidulafungin
Echinocandins

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012