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

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma Taiwan, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189709

Purpose

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

Condition	Intervention	Phase
Invasive Candidiasis Candidemia	Drug: Micafungin Drug: fluconazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Fluconazole FK 463 Micafungin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	24
Study Start Date:	August 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Micafungin IV Other Name: FK463
Active Comparator: 2	Drug: fluconazole IV Other Name: Diflucan

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189709

Locations

Taiwan

Taipei, Republic of China, Taiwan, 100

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Taiwan, Inc.

Investigators

Principal Investigator:

Shan-Chwen Chang, MD

National Taiwan University Hospital

More Information

No publications provided

Responsible Party:	Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier:	NCT00189709 History of Changes
Other Study ID Numbers:	MCFGCAN-0301F-TW
Study First Received:	September 12, 2005
Last Updated:	December 26, 2007
Health Authority:	Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:

micafungin
fluconazole
invasive candidiasis
candidemia

Additional relevant MeSH terms:

Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

Fluconazole
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012