The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis

Overview

Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.

Full Title of Study: “A Phase III, Double-Blind, Randomized, Multi-Center, Study of the Safety and Efficacy of Anidulafungin vs. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Detailed Description

Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Interventions

  • Drug: Anidulafungin
  • Drug: Fluconazole

Participating in This Clinical Trial

  • Diagnosis of candidemia and/or other forms of invasive candidiasis. – Should not have received greater than 48 hours of systemic antifungal therapy. – Life expectancy should be greater than 72 hours. – Should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment
  • Gender Eligibility: All

    Minimum Age: 16 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Pfizer
    • Collaborator
      • Vicuron Pharmaceuticals
    • Provider of Information About this Clinical Study
      • Director, Clinical Trial Disclosure Group, Pfizer, Inc.

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