Status:
COMPLETED
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Candidiasis
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 i...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT00106288
Start Date
January 1 2003
End Date
December 1 2005
Last Update
September 18 2014
Active Locations (37)
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1
Birmingham, Alabama, United States, 35294-0006
2
Orange, California, United States, 92868
3
Denver, Colorado, United States, 80218
4
Washington D.C., District of Columbia, United States, 20010-2970