Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Candidemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189709
• Other study ID #: MCFGCAN-0301F-TW
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 26, 2007
• Start date: August 2004
• Est. completion date: July 2006

Study information

• Verified date: December 2007
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

Drug:
• Micafungin
IV
• fluconazole
IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		2-8 Weeks	No
Secondary	Clinical response, mycological response		2-8 weeks	No