Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00189709

Collaborator

Astellas Pharma Taiwan, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Aug 1, 2004

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: Micafungin

Other Names:

FK463

Active Comparator: 2

Drug: fluconazole

Other Names:

Diflucan

Outcome Measures

Primary Outcome Measures

Response rate [2-8 Weeks]

Secondary Outcome Measures

Clinical response, mycological response [2-8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.