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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Vicuron Pharmaceuticals
• Treatments: Anidulafungin; Echinocandins

Criteria

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