Back to resultsThe Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Primary Purpose
Candidiasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anidulafungin
Fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis focused on measuring Candida blood stream infections, Candida infections, Candidemia, Invasive Candidiasis
Eligibility Criteria
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
Sites / Locations
- Versicor, Inc.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00056368
First Posted
March 11, 2003
Last Updated
October 17, 2008
Sponsor
Pfizer
Collaborators
Vicuron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00056368
Brief Title
The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Official Title
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
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Vicuron Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
Keywords
Candida blood stream infections, Candida infections, Candidemia, Invasive Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Intervention Type
Drug
Intervention Name(s)
Fluconazole
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Versicor, Inc.
City
King of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17568028
Citation
Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. doi: 10.1056/NEJMoa066906.
Results Reference
derived
Learn more about this trial
The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
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