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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00056368

Collaborator

Vicuron Pharmaceuticals (Industry)

256

Enrollment

Location

19.1

Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Mar 1, 2003

Actual Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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