The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-08-31

Brief Summary

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Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.

Detailed Description

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Conditions

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Candidiasis

Keywords

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Azole-Refractory Mucosal Candidiasis Mucosal Candidiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

* Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole)
* Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast

Exclusion Criteria

* Pregnant female
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
* Abnormal blood chemistries: Bilirubin \>2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 4 times the upper limit of normal
* Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents
* Patients taking other systemic antifungal therapies while on this study

Minimum Eligible Age

12 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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A8851004

Identifier Type: -

Identifier Source: secondary_id

VER002-11