Back to resultsMicafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
Primary Purpose
Invasive Candidiasis, Candidemia
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Micafungin
fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Candidiasis focused on measuring micafungin, fluconazole, invasive candidiasis, candidemia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Clinical response, mycological response
Full Information
NCT ID
NCT00189709
First Posted
September 12, 2005
Last Updated
December 26, 2007
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00189709
Brief Title
Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Taiwan, Inc.
4. Oversight
5. Study Description
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiasis, Candidemia
Keywords
micafungin, fluconazole, invasive candidiasis, candidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
fluconazole
Other Intervention Name(s)
Diflucan
Intervention Description
IV
Primary Outcome Measure Information:
Title
Response rate
Time Frame
2-8 Weeks
Secondary Outcome Measure Information:
Title
Clinical response, mycological response
Time Frame
2-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan-Chwen Chang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
City
Taipei
State/Province
Republic of China
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
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