Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Condition(s) targeted: Candidiasis

Intervention: Micafungin (Drug); Liposomal Amphotericin B (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Europe B.V.

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

Official title: A Multicenter, Double Blind, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Micafungin (FK463) Versus Liposomal Amphotericin B (AmBisome) in the Treatment of Invasive Candidiasis and Candidemia

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

Primary outcome: Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.

Secondary outcome:

Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period

Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period

Overall incidence of emergent and recurrent fungal infections at the End of Study

Independent Efficacy Review Committee's assessment of overall treatment success

Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline

Incidence of acute infusion related reactions as pre-defined

Patient survival at the End of Therapy and at the End of Study

Overall incidence of Adverse Events (AE)

Detailed description: A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.

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

Criteria:

Inclusion Criteria:

Patients either non-neutropenic with absolute neutrophil counts >= 500 cells/mm3 or neutropenic with absolute neutrophil counts < 500 cells/mm3 must have:

- Candidemia or invasive candidiasis,

- Confirmation and typical clinical signs and symptoms by fungal culture and/or

histology,

- Positive culture obtained no more than four days prior to the first dose of study

medication.

Exclusion Criteria:

- Patient is pregnant or nursing

- Patients with evidence of liver disease as defined by: a) SGOT/AST or SGPT/ALT > 10

times the upper limit of normal (ULN); or b) Total bilirubin > 5 times ULN.

- Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or

with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains.

- Patients who have received prophylactic/empiric therapy with azoles or conventional

amphotericin B for more than three days within one week prior to enrollment. Neutropenic patients, however, may have received prophylactic azoles without time restrictions.

Quebec G1R 2J6, Canada

Birmingham, Alabama 35294-0006, United States

Calgary, Alberta T2N 2T9, Canada

Vancouver, British Columbia V6Z 1Y6, Canada

Orange, California 92868, United States

Denver, Colorado 80218, United States

Washington, DC, District of Columbia 20010-2970, United States

Jacksonville, Florida 32207, United States

Atlanta, Georgia 30322, United States

Maywood, Illinois 60153, United States

Hinsdale, Illinois 60521, United States

Kansas City, Kansas 66160, United States

Lexington, Kentucky 40536-0084, United States

Winnipeg, Manitoba R3A 1R9, Canada

Baltimore, Maryland 21201-1595, United States

Boston, Massachusetts 02115, United States

Boston, Massachusetts 02211, United States

Detroit, Michigan 48201, United States

Minneapolis, Minnesota 55455, United States

New York, New York 10029, United States

Rochester, New York 14642, United States

Valhalla, New York 10595, United States

New York, New York 10032, United States

New York, New York 10021, United States

Durham, North Carolina 27710, United States

Halifax, Nova Scotia B3H 2Y9, Canada

Toronto, Ontario M5S 2N9, Canada

Hamilton, Ontario L8V 1C3, Canada

Philadelphia, Pennsylvania 19140, United States

Philadelphia, Pennsylvania 19107, United States

Philadelphia, Pennsylvania 19104, United States

Montreal, Quebec H2L 4M1, Canada

Montreal, Quebec H1T 2M4, Canada

Regina, Saskatchewan S4P OW5, Canada

Houston, Texas 77030, United States

San Antonio, Texas 78229-3900, United States

Provo, Utah 84604, United States

Click here for more information about the sponsor/collaborator: Fujisawa Healthcare, Inc.

Starting date: January 2003
Ending date: November 2004
Last updated: March 31, 2008