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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00041704. Last updated on October 17, 2008. Information provided by Pfizer

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Candidiasis
Intervention ^†	Drug: Anidulafungin, VER002
MEDLINE PMIDs
Links	Link to ClinicalStudyResults.org Posting

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	19
Start Date ^†	August 2002
Completion Date	August 2004
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
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00041704
Organization ID	VER002-11
Secondary IDs ^††	A8851004
Study Sponsor ^†	Pfizer
Collaborators ^††	Vicuron Pharmaceuticals
Investigators ^†
Information Provided By	Pfizer
Verification Date	October 2008
First Received Date ^†	July 12, 2002
Last Updated Date	October 17, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.