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Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma Taiwan, Inc. |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00189709 |
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
Condition | Intervention | Phase |
---|---|---|
Invasive Candidiasis Candidemia |
Drug: Micafungin Drug: fluconazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single Center, Open, Parallel, Comparative, Randomized Study of Micafungin (FK463) vs Fluconazole (Diflucan) in the Treatment of Invasive Candidiasis and Candidaemia (Protocol No: MCFGCAN-0301F-TW) |
Enrollment: | 24 |
Study Start Date: | August 2004 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Micafungin
IV
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2: Active Comparator |
Drug: fluconazole
IV
|
Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan, Republic of China | |
Taipei, Republic of China, Taiwan, 100 |
Principal Investigator: | Shan-Chwen Chang, MD | National Taiwan University Hospital |
Responsible Party: | Astellas Pharma, Inc ( Director ) |
Study ID Numbers: | MCFGCAN-0301F-TW |
Study First Received: | September 12, 2005 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00189709 History of Changes |
Health Authority: | Taiwan: Department of Health |
micafungin fluconazole invasive candidiasis candidemia |
Fluconazole Mycoses Candidiasis Clotrimazole |
Miconazole Antifungal Agents Tioconazole Micafungin |
Fluconazole Anti-Infective Agents Mycoses Candidiasis |
Therapeutic Uses Antifungal Agents Pharmacologic Actions Micafungin |