The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis
Intervention: Anidulafungin (Drug); Fluconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
Versicor, Inc., King of Prussia, Pennsylvania 19406, United States
Additional Information
Related publications: 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.
Starting date:
March 2003
Ending date: October 2004
Last updated: February 28, 2007
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