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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00056368
Recruitment Status : Completed
First Posted : March 12, 2003
Last Update Posted : October 21, 2008
Sponsor:
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Candidiasis Drug: Anidulafungin Drug: Fluconazole Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2003
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056368


Locations
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United States, Pennsylvania
Versicor, Inc.
King of Prussia, Pennsylvania, United States, 19406
Sponsors and Collaborators
Pfizer
Vicuron Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00056368    
Other Study ID Numbers: VER002-9
A8851002
First Posted: March 12, 2003    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008
Keywords provided by Pfizer:
Candida blood stream infections
Candida infections
Candidemia
Invasive Candidiasis
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Bacterial Infections and Mycoses
Infections
Invasive Fungal Infections
Fungemia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
 Anidulafungin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors