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
  Purpose

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 Intervention Phase
Candidiasis
Drug: Anidulafungin
Drug: Fluconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Enrollment: 256
Study Start Date: March 2003
Study Completion Date: October 2004
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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056368

Locations
United States, Pennsylvania
Versicor, Inc.
King of Prussia, Pennsylvania, United States, 19406
Sponsors and Collaborators
Pfizer
Vicuron Pharmaceuticals
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00056368     History of Changes
Other Study ID Numbers: VER002-9, A8851002
Study First Received: March 11, 2003
Last Updated: October 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Candida blood stream infections
Candida infections
Candidemia
Invasive Candidiasis

Additional relevant MeSH terms:
Candidemia
Candidiasis
Candidiasis, Invasive
Fungemia
Infection
Inflammation
Mycoses
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Anidulafungin
Echinocandins
Fluconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014