Study of Micafungin in Patients With Invasive Candidiasis or Candidemia - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00105144

Purpose

The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Condition	Intervention	Phase
Candidiasis Candidemia	Drug: Micafungin Drug: Caspofungin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Caspofungin Caspofungin Acetate Micafungin sodium

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy [ Time Frame: End of therapy and 6 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy [ Time Frame: End of therapy and 6 weeks post-treatment ] [ Designated as safety issue: No ]

Enrollment:	611
Study Start Date:	September 2004
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 lower dose	Drug: Micafungin IV Other Names: Mycamine FK463
Experimental: 2 higher dose	Drug: Micafungin IV Other Names: Mycamine FK463
Active Comparator: 3	Drug: Caspofungin IV Other Name: Cancidas

Detailed Description:

The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have candidemia or invasive candidiasis.

Exclusion Criteria:

Patients who have received an echinocandin within one month prior to study entry.
Patients who have received more than two days of prior systemic antifungal therapy for the current infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105144

Show 167 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. Epub 2010 Dec 8.

Responsible Party:	Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier:	NCT00105144 History of Changes
Obsolete Identifiers:	NCT00235742
Other Study ID Numbers:	03-0-192
Study First Received:	March 7, 2005
Last Updated:	June 27, 2008
Health Authority:	United States: Food and Drug Administration Brazil: National Health Surveillance Agency Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - French Health Products Safety Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency India: Ministry of Health Canada: Health Canada Belgium: Ministry of Social Affairs, Public Health and the Environment Spain: Ministry of Health Poland: Ministry of Health Czech Republic: State Institute for Drug Control Croatia: Ministry of Health and Social Care Netherlands: Medicines Evaluation Board (MEB) Switzerland: Swissmedic Austria: Federal Office for Safety in Health Care

Keywords provided by Astellas Pharma Inc:

Treatment Effectiveness
Treatment Efficacy
Investigational, Therapies

Antifungal, Systemic
Antibiotics, Antifungal
Micafungin

Additional relevant MeSH terms:

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

Inflammation
Pathologic Processes
Antifungal Agents
Caspofungin
Micafungin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012