Taipei, Republic of China, 100, Taiwan
NCT Number: NCT00189709
Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
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Notify MeKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
Micafungin
DrugIV
Other names: FK463
Fluconazole
DrugIV
Other names: Diflucan
Primary outcomes
-
Response rate
Time frame: 2-8 Weeks
Secondary outcomes
-
Clinical response, mycological response
Time frame: 2-8 weeks
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Collaborators
- Astellas Pharma Taiwan, Inc.
Registry information
Official study 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)
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Sep 19, 2005
- Registry last updated
- Jan 2, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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