Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Last updated: December 26, 2007
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

3

Condition

Fungal Infections

Systemic Candidiasis

Vaginal Infection

Treatment

N/A

Clinical Study ID

NCT00189709
MCFGCAN-0301F-TW
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 hoursof prior systemic antifungal therapy

  • Inpatients aged 16 and above

Exclusion

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 fluconazoleor echinocandin with no response.

  • Patients who have prior antifungal infection requiring treatment with systemicantifungal agents for conditions other than candidemia and invasive candidiasis.

Study Design

Total Participants: 24
Study Start date:
August 01, 2004
Estimated Completion Date:
July 31, 2006

Study 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.

Connect with a study center

  • Taipei, Republic of China 100
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.