Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Candidiasis; Candidemia
Intervention: Micafungin (Drug); fluconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Shan-Chwen Chang, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
Summary
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in
treating patients with invasive candidiasis or candidaemia
Clinical Details
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)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Response rate
Secondary outcome: Clinical response, mycological response
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) 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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Taipei, Republic of China 100, Taiwan
Additional Information
Starting date: August 2004
Ending date: July 2006
Last updated: December 26, 2007
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