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

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

This study has been completed.

Sponsors and Collaborators:	Pfizer 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

MedlinePlus related topics:

Yeast Infections

ChemIDplus related topics:

Anidulafungin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Study Start Date:	August 2001
Estimated 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

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	VER002-6
First Received:	May 16, 2002
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00037219
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Anidulafungin

Candidemia

Invasive Candidiasis

Study placed in the following topic categories:

Mycoses

Candidiasis

Clotrimazole

Miconazole

Tioconazole

Anidulafungin

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antifungal Agents

Antibiotics, Antifungal

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008