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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Candidiasis

Keywords

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Anidulafungin Candidemia Invasive Candidiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anidulafungin, VER002

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer, Inc.

Locations

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Versicor, Inc.

King of Prussia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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A8851018

Identifier Type: -

Identifier Source: secondary_id

VER002-6