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

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.

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Candidemia Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Versicor, Inc.

King of Prussia, Pennsylvania, 19406, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anidulafungin

Drug

Fluconazole

Drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

Vicuron Pharmaceuticals

Registry information

Official study 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.

Important dates

Study start: 2003
Study completion: 2004
First posted: Mar 12, 2003
Registry last updated: Oct 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed