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OpenTrials
Completed

NCT Number: NCT00189709

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

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

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micafungin

Drug

IV

Other names: FK463

Fluconazole

Drug

IV

Other names: Diflucan

Primary outcomes

  1. Response rate

    Time frame: 2-8 Weeks

Secondary outcomes

  1. Clinical response, mycological response

    Time frame: 2-8 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Taiwan, Inc.

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.