Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189709

Enrollment

Registered

2005-09-19

Start date

2004-08-31

Completion date

2006-07-31

Last updated

2008-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidemia, Invasive Candidiasis

Keywords

micafungin, fluconazole, invasive candidiasis, candidemia

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.

Interventions

DRUGMicafungin

DRUGfluconazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Response rate	2-8 Weeks

Secondary

Measure	Time frame
Clinical response, mycological response	2-8 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026