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The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

This study has been completed.
Sponsor:
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00037219
First received: May 16, 2002
Last updated: October 17, 2008
Last verified: October 2008
History of Changes
  Purpose

Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.


Condition Intervention Phase
Candidiasis
 Drug: Anidulafungin, VER002
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Further study details as provided by Pfizer:

Enrollment: 120
Study Start Date: August 2001
Study Completion Date: November 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
  • Life expectancy: greater than 72 hours

Exclusion Criteria:

  • Pregnant Females
  • Treatment with other investigational drug(s) within 4 weeks
  • Hypersensitivity to anidulafungin or echinocandin therapy
  • Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037219

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: NCT00037219     History of Changes
Other Study ID Numbers: VER002-6, A8851018
Study First Received: May 16, 2002
Last Updated: October 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Anidulafungin
Candidemia
Invasive Candidiasis

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

ClinicalTrials.gov processed this record on May 19, 2013