Back to resultsThe Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
Primary Purpose
Candidiasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anidulafungin, VER002
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis focused on measuring Anidulafungin, Candidemia, Invasive Candidiasis
Eligibility 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
Sites / Locations
- Versicor, Inc.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037219
First Posted
May 16, 2002
Last Updated
October 17, 2008
Sponsor
Pfizer
Collaborators
Vicuron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00037219
Brief Title
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Vicuron Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
Keywords
Anidulafungin, Candidemia, Invasive Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anidulafungin, VER002
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Versicor, Inc.
City
King of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.
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