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

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

This study has been completed.

Sponsors and Collaborators:	Pfizer 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

MedlinePlus related topics:

Yeast Infections

ChemIDplus related topics:

Anidulafungin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Estimated Enrollment:	20
Study Start Date:	August 2002
Estimated 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

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	VER002-11
First Received:	July 12, 2002
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00041704
Health Authority:	United States: Food and Drug Administration