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

Condition(s) targeted: Invasive Fungal Infections

Intervention: Micafungin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

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.

Official title: 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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome: Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Birmingham, Alabama 35294, United States

Little Rock, Arkansas 72205, United States

Los Angeles, California 90048, United States

Los Angeles, California 90033, United States

Oakland, California 94609, United States

Orange, California 92868, United States

Sacramento, California 95817, United States

San Francisco, California 94110, United States

Santa Barbara, California 93102, United States

Stanford, California 94305, United States

Stanford, California 94304, United States

Denver, Colorado 80262, United States

Washington, District of Columbia 20010, United States

Washington D.C., District of Columbia 20010, United States

Tampa, Florida 33601, United States

Atlanta, Georgia 30303, United States

Maywood, Illinois 60153, United States

Indianapolis, Indiana 46202, United States

Indianapolis, Indiana 46390, United States

Indianapolis, Indiana 46260, United States

Portland, Maine 04102, United States

Baltimore, Maryland 21201, United States

Baltimore, Maryland 21287, United States

Boston, Massachusetts 02114, United States

Detroit, Michigan 48201, United States

Minneapolis, Minnesota 55455, United States

St. Louis, Missouri 63110, United States

Omaha, Nebraska 68198, United States

Newark, New Jersey 07103, United States

Rochester, New York 14642, United States

Durham, North Carolina 27110, United States

Durham, North Carolina 27710, United States

Cincinnati, Ohio 45267, United States

Hamilton, Ontario L8V 1C3, Canada

London, Ontario N6A 5A5, Canada

Ottawa, Ontario K1H 8L6, Canada

Hershey, Pennsylvania 17033, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15213, United States

Greenfield Park, Quebec J4V 2H1, Canada

Montreal, Quebec H3A 1A1, Canada

Saskatoon, Saskatchewan S7N0W8, Canada

Regina, Saskatchewan S4P 0W5, Canada

Nashville, Tennessee 37212, United States

Dallas, Texas 75246, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84132, United States

Charlottesville, Virginia 22906, United States

Seattle, Washington 98104, United States

Click here for more information about the sponsor: Fujisawa Helathcare, Inc.

Starting date: January 2003
Ending date: June 2003
Last updated: March 29, 2008