A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

NCT ID: NCT00423163

Last Updated: 2015-09-02

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

Detailed Description

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Conditions

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Aspergillosis/Blood Aspergillosis/Invasive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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micafungin

Intervention Type DRUG

voriconazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Proven, probable or possible invasive aspergillosis
* Patient is 2 years of age or older

Exclusion Criteria

* The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for \>7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
* The patient has been treated with voriconazole for \> 7 days immediately prior to randomization
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

Fountain Valley, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Beech Grove, Indiana, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Charlestown, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Omaha, Nebraska, United States

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Albany, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Countries

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United States

Other Identifiers

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20-05-002

Identifier Type: -

Identifier Source: org_study_id

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