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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Candidiasis

Treatments: Drug: Anidulafungin, VER002

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037219

A8851018

VER002-6

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)