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The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis

This study has been completed.
Sponsor:
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00056368
First received: March 11, 2003
Last updated: October 17, 2008
Last verified: October 2008

March 11, 2003
October 17, 2008
March 2003
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Complete list of historical versions of study NCT00056368 on ClinicalTrials.gov Archive Site
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The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Candidiasis
  • Drug: Anidulafungin
  • Drug: Fluconazole
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
October 2004
Not Provided
  • 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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00056368
VER002-9, A8851002
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Vicuron Pharmaceuticals
Not Provided
Pfizer
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP