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

Tracking Information
First Received Date ^ICMJE	March 11, 2003
Last Updated Date	October 17, 2008
Start Date ^ICMJE	March 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00056368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Official Title ^ICMJE	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.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Candidiasis
Intervention ^ICMJE	Drug: Anidulafungin Drug: Fluconazole
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	256
Completion Date	October 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00056368
Responsible Party	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers ^ICMJE	VER002-9, A8851002
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Vicuron Pharmaceuticals
Investigators ^ICMJE
Information Provided By	Pfizer
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP