Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

Condition(s) targeted: Candidiasis; Candidemia

Intervention: Micafungin (Drug); Caspofungin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

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

The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Official title: A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy

Secondary outcome: Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy

Detailed description: The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have candidemia or invasive candidiasis.

Exclusion Criteria:

- Patients who have received an echinocandin within one month prior to study entry.

- Patients who have received more than two days of prior systemic antifungal therapy for

the current infection.

Wien 1090, Austria

Aalst 9300, Belgium

Brussels 1000, Belgium

Brussel 1090, Belgium

Brussel 1200, Belgium

Gent 9000, Belgium

Liege 4800, Belgium

Brussels 1070, Belgium

Belo Horizonte 30110-908, Brazil

Belo Horizonte 30130-110, Brazil

Belo Horizonte 30190-130, Brazil

Salvador 40050-410, Brazil

Salvador 40110-160, Brazil

Sao Paulo 01500-000, Brazil

Sao Paulo 04012-180, Brazil

Sao Paulo 04040-002, Brazil

Quebec G1R 2J6, Canada

Zagreb 10000, Croatia

Prague 14021, Czech Republic

Paris Cedex 13 75651, France

Paris Cedex 14 75674, France

Villejuif Cedex 94084, France

Strasbourg 67098, France

Paris Cedex 18 75877, France

Bobigny 93009, France

Villejuif Cedex 94805, France

Paris Cedex 04 75181, France

Metz 57000, France

Hannover 30625, Germany

Berlin 10117, Germany

Frankfurt 60590, Germany

Koln 50937, Germany

Bielefeld 33611, Germany

Ulm 89081, Germany

Wurzburg 97070, Germany

Cochin, India

Hyderabad 500 009, India

Mumbai 400 026, India

Hyderabad 500 082, India

Hyderabad 500 034, India

Bangalore 560017, India

Banglore 560 054, India

Chennai 600 006, India

Hyderabad 500 033, India

Lucknow 226 014, India

Kolkotta 700 029, India

Ludhiana 141 009, India

Mangalore 575 001, India

Bangalore, India

Bangalore 56017, India

Cochin Kerala 682 026, India

Manipal 576 104, India

Chennai 35, India

Uttar Pradesh 201 301, India

Mumbai 400 012, India

Chandigarh, India

Groningen 9700 RB, Netherlands

Gdansk 80-211, Poland

Lodz 93-513, Poland

Warsaw 00-957, Poland

Barcelona 08003, Spain

Barcelona 08025, Spain

Barcelona 08035, Spain

Barcelona 08036, Spain

Barakaldo 48903, Spain

Madrid 28005, Spain

Madrid 28007, Spain

Madrid 28034, Spain

Madrid 28041, Spain

Santander 39008, Spain

Valencia 46009, Spain

Sevilla 41014, Spain

Salamanca 37007, Spain

St. Gallen 9007, Switzerland

Birmingham, Alabama 35294, United States

Edmonton, Alberta T6G 2B7, Canada

Little Rock, Arkansas 72205, United States

Kelowna, British Columbia V1Y 1T2, Canada

San Francisco, California 94115, United States

Los Angeles, California 90033, United States

Los Angeles, California 90095, United States

Denver, Colorado 80262, United States

Denver, Colorado 80204, United States

Washington, District of Columbia 20010, United States

London, England SE1 7EH, United Kingdom

London, England W6 8RF, United Kingdom

London, England SW10 9NH, United Kingdom

Manchester, England M23 9LT, United Kingdom

Bay Pines, Florida 33744, United States

Miami, Florida 33136, United States

Glasgow, GB G11 6NT, United Kingdom

Leeds, GB LS9 7TF, United Kingdom

Leeds, GB LS1 3EX, United Kingdom

Augusta, Georgia 30912, United States

Atlanta, Georgia 30322, United States

Augusta, Georgia 30909, United States

Maywood, Illinois 60153, United States

Chicago, Illinois 60637, United States

Chicago, Illinois 60612, United States

Beech Grove, Indiana 46107, United States

Evansville, Indiana 47714, United States

Iowa City, Iowa 52242, United States

Des Moines, Iowa 50309, United States

Kansas City, Kansas 66160, United States

Wichita, Kansas 67214, United States

Lexington, Kentucky 40536, United States

New Orleans, Louisiana 70121, United States

Winnipeg, Manitoba R3A 1R9, Canada

Baltimore, Maryland 21201, United States

Baltimore, Maryland 21287, United States

Boston, Massachusetts 02115, United States

Boston, Massachusetts 02215, United States

Boston, Massachusetts 02111, United States

Detroit, Michigan 48201, United States

Detroit, Michigan 48202, United States

Minneapolis, Minnesota 55455, United States

Jackson, Mississippi 39216, United States

St. Louis, Missouri 63310, United States

Neptune, New Jersey 07754, United States

Rochester, New York 14642, United States

Manhasset, New York 11030, United States

New York, New York 10029, United States

Bronx, New York 10467, United States

Valhalla, New York 10595, United States

Albany, New York 12208, United States

New Hyde Park, New York 11040, United States

Stonybrook, New York 11794, United States

New York, New York 10032, United States

St. John's, Newfoundland and Labrador A1B 3V6, Canada

Durham, North Carolina 27710, United States

Winston-Salem, North Carolina 27157, United States

Halifax, Nova Scotia B3H 1V7, Canada

Columbus, Ohio 43210, United States

Cincinnati, Ohio 45267, United States

Ottawa, Ontario K1H 8L6, Canada

Hamilton, Ontario L8V 1C3, Canada

Toronto, Ontario M5G 2N2, Canada

Kingston, Ontario K7L 2V7, Canada

Cunitiba, PR-CEP 80060-900, Brazil

West Reading, Pennsylvania 19611, United States

Allentown, Pennsylvania 18103, United States

Philadelphia, Pennsylvania 19140, United States

Pittsburg, Pennsylvania 15213, United States

Philadelphia, Pennsylvania 19104, United States

Chicoutimi, Quebec G7H 5H6, Canada

Greenfield Park, Quebec J4V 2H1, Canada

Montreal, Quebec H1T 2M4, Canada

Montreal, Quebec H2X 2P4, Canada

Rio de Janeiro, RJ 21941-590, Brazil

Porto Alegre, RS, Brazil

Providence, Rhode Island 02908, United States

São Paulo, SP 04039-020, Brazil

Santos, SP 11045-904, Brazil

São José do Rio Preto, SP 15090-000, Brazil

Regina, Saskatchewan S4P 0W5, Canada

Saskatoon, Saskatchewan S7N 0W8, Canada

Jackson, Tennessee 38301, United States

Memphis, Tennessee 38104, United States

Houston, Texas 77030, United States

San Antonio, Texas 78229, United States

Dallas, Texas 75246, United States

Charlottesville, Virginia 22908, United States

Fairfax, Virginia 22030, United States

Seattle, Washington 98109, United States

Belo Horizonte, mg 30190-081, Brazil

Belo Horizonte, mg-CEP 30190-081, Brazil

Belo Horizonte, mg-CEP 30140-093, Brazil

Starting date: September 2004
Ending date: April 2006
Last updated: March 29, 2008