Status:
COMPLETED
Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Taiwan, Inc.
Conditions:
Invasive Candidiasis
Candidemia
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
Detailed Description
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) t...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of candidemia and invasive candidiasis
- Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy
- Inpatients aged 16 and above
Exclusion
- Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).
- Patients with severe complications in the liver
- Pregnant or lactating women
- Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.
- Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00189709
Start Date
August 1 2004
End Date
July 1 2006
Last Update
January 2 2008
Active Locations (1)
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1
Taipei, Republic of China, Taiwan, 100