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NCT00056368 Clinical Trial

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

Candidiasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00056368
Other study ID # VER002-9
Secondary ID A8851002
Status Completed
Phase Phase 3
First received March 11, 2003
Last updated October 17, 2008
Start date March 2003
Est. completion date October 2004

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anidulafungin

• Fluconazole

Locations
Country Name City State
United States Versicor, Inc. King of Prussia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States, 

See also
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