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

This study has been completed.

First Received on May 16, 2002. Last Updated on October 17, 2008 History of Changes

Sponsor:	Pfizer
Collaborator:	Vicuron Pharmaceuticals
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00037219

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 II

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

Drug Information available for: Anidulafungin

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 February 13, 2012