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Completed

NCT Number: NCT00041704

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

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.

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Infections Mycoses

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Versicor, Inc.

King of Prussia, Pennsylvania, 19406, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anidulafungin, VER002

Drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Vicuron Pharmaceuticals

Registry information

Official study title

A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.

Important dates

Study start
2002
Study completion
2004
First posted
Jul 16, 2002
Registry last updated
Oct 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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