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)”

To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Micafungin
  • IV
• Drug: fluconazole
  • IV

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Response rate
  • Time Frame: 2-8 Weeks
    Safety Issue?: No

Secondary Measures

• Clinical response, mycological response
  • Time Frame: 2-8 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Shan-Chwen Chang, MD Principal Investigator National Taiwan University Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00189709

Study ID Number: MCFGCAN-0301F-TW

ClinicalTrials.gov Identifier: NCT00189709

Health Authority: Taiwan: Department of Health