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

March 26, 2012 updated by: Astellas Pharma Inc

A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H 8L6
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H3A 1A1
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
      • Saskatoon, Saskatchewan, Canada, S7N0W8
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90033
      • Oakland, California, United States, 94609
      • Orange, California, United States, 92868
      • Sacramento, California, United States, 95817
      • San Francisco, California, United States, 94110
      • Santa Barbara, California, United States, 93102
      • Stanford, California, United States, 94305
      • Stanford, California, United States, 94304
    • Colorado
      • Denver, Colorado, United States, 80262
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
      • Washington D.C., District of Columbia, United States, 20010
    • Florida
      • Tampa, Florida, United States, 33601
    • Georgia
      • Atlanta, Georgia, United States, 30303
    • Illinois
      • Maywood, Illinois, United States, 60153
    • Indiana
      • Indianapolis, Indiana, United States, 46260
      • Indianapolis, Indiana, United States, 46202
      • Indianapolis, Indiana, United States, 46390
    • Maine
      • Portland, Maine, United States, 04102
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • New York
      • Rochester, New York, United States, 14642
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Durham, North Carolina, United States, 27110
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
    • Tennessee
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Dallas, Texas, United States, 75246
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Charlottesville, Virginia, United States, 22906
    • Washington
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Placebo Comparator: 2
Drug: Placebo
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study
Time Frame: Baseline through one week post-treatment
Baseline through one week post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
Time Frame: Baseline through one week post-treatment
Baseline through one week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma US, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

November 6, 2002

First Submitted That Met QC Criteria

November 7, 2002

First Posted (Estimate)

November 8, 2002

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-0-124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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