Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Completed · Phase 3

Conditions studied: Candidiasis

In brief

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.

Key facts

Study ID

NCT00106288

Run by

Astellas Pharma Inc

People needed

637

Starts

2003-01-01

Expected to finish

2005-12-01

Last updated by the study team

2014-09-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Orange, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Hinsdale, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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