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

Tracking Information
First Received Date ^ICMJE	July 12, 2002
Last Updated Date	October 17, 2008
Start Date ^ICMJE	August 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00041704 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)
Official Title ^ICMJE	A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Candidiasis
Intervention ^ICMJE	Drug: Anidulafungin, VER002
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	19
Completion Date	August 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00041704
Responsible Party	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers ^ICMJE	VER002-11, A8851004
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Vicuron Pharmaceuticals
Investigators ^ICMJE
Information Provided By	Pfizer
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP