Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

NCT ID: NCT00048750

Last Updated: 2012-03-27

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-06-30

Brief Summary

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The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.

Detailed Description

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Conditions

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Invasive Fungal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

IV

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV

Interventions

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Micafungin

IV

Intervention Type DRUG

Placebo

IV

Intervention Type DRUG

Other Intervention Names

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Mycamine FK463

Eligibility Criteria

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Inclusion Criteria

* Meets entry criteria for high risk

Exclusion Criteria

* Evidence of active invasive fungal infection
* Received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug
* Known to be HIV positive who have CD4 count less than 500 cells/mm3
* Has life-expectancy of less than 72 hours or moribund
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma US, Inc.

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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Orange, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Santa Barbara, California, United States

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Stanford, California, United States

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Stanford, 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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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Maywood, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Newark, New Jersey, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Countries

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United States Canada

Other Identifiers

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01-0-124

Identifier Type: -

Identifier Source: org_study_id

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