The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Versicor, Inc.

King of Prussia, Pennsylvania, 19406, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
Life expectancy: greater than 72 hours

Exclusion criteria

Pregnant Females
Treatment with other investigational drug(s) within 4 weeks
Hypersensitivity to anidulafungin or echinocandin therapy
Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

Treatment and study plan

Anidulafungin, VER002

Drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

Vicuron Pharmaceuticals

Registry information

Official study title

A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis

Important dates

Study start: 2001
Study completion: 2002
First posted: May 17, 2002
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