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

This study has been completed.
Sponsor:
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00041704
First received: July 12, 2002
Last updated: October 17, 2008
Last verified: October 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Enrollment: 19
Study Start Date: August 2002
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00041704     History of Changes
Other Study ID Numbers: VER002-11, A8851004
Study First Received: July 12, 2002
Last Updated: October 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Azole-Refractory Mucosal Candidiasis
Mucosal Candidiasis

Additional relevant MeSH terms:
Candidiasis
Mycoses
Anidulafungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014