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

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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 This link exits the ClinicalTrials.gov site
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.




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