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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041704
First Posted: July 16, 2002
Last Update Posted: October 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer
July 12, 2002
July 16, 2002
October 20, 2008
August 2002
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Complete list of historical versions of study NCT00041704 on ClinicalTrials.gov Archive Site
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The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)
A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Candidiasis
Drug: Anidulafungin, VER002
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
August 2004
Not Provided

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00041704
VER002-11
A8851004
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Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Vicuron Pharmaceuticals
Not Provided
Pfizer
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP