Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 26, 2007

Start Date ^ICMJE

August 2004

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate [ Time Frame: 2-8 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00189709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical response, mycological response [ Time Frame: 2-8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Official Title ^ICMJE

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)

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Invasive Candidiasis
Candidemia

Intervention ^ICMJE

Drug: Micafungin
Drug: fluconazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00189709

Responsible Party

Director, Astellas Pharma, Inc

Study ID Numbers ^ICMJE

MCFGCAN-0301F-TW

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Astellas Pharma Taiwan, Inc.

Investigators ^ICMJE

Principal Investigator:

Shan-Chwen Chang, MD

National Taiwan University Hospital

Information Provided By

Astellas Pharma Inc

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP