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Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

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ClinicalTrials.gov Identifier: NCT00189709
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 2, 2008
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Invasive Candidiasis Candidemia Drug: Micafungin Drug: fluconazole Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Micafungin
IV
Other Name: FK463
Active Comparator: 2 Drug: fluconazole
IV
Other Name: Diflucan



Primary Outcome Measures :
  1. Response rate [ Time Frame: 2-8 Weeks ]

Secondary Outcome Measures :
  1. Clinical response, mycological response [ Time Frame: 2-8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189709


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00189709     History of Changes
Other Study ID Numbers: MCFGCAN-0301F-TW
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 2, 2008
Last Verified: December 2007

Keywords provided by Astellas Pharma Inc:
micafungin
fluconazole
invasive candidiasis
candidemia

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors