Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

This study has been completed.
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: December 26, 2007
Last verified: December 2007
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Condition Intervention Phase
Invasive Candidiasis
Drug: Micafungin
Drug: fluconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Response rate [ Time Frame: 2-8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response, mycological response [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Micafungin
Other Name: FK463
Active Comparator: 2 Drug: fluconazole
Other Name: Diflucan

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.

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00189709

Taipei, Republic of China, Taiwan, 100
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Principal Investigator: Shan-Chwen Chang, MD National Taiwan University Hospital
  More Information

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00189709     History of Changes
Other Study ID Numbers: MCFGCAN-0301F-TW 
Study First Received: September 12, 2005
Last Updated: December 26, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
invasive candidiasis

Additional relevant MeSH terms:
Candidiasis, Invasive
Pathologic Processes
Systemic Inflammatory Response Syndrome
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016