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

Sponsored by:	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 III

MedlinePlus related topics: Yeast Infections

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole Tioconazole Caspofungin Caspofungin Acetate FK 463 Micafungin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental lower dose	Drug: Micafungin IV
2: Experimental higher dose	Drug: Micafungin IV
3: Active Comparator	Drug: Caspofungin IV

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

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	03-0-192
Study First Received:	March 7, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00105144 History of Changes
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

Study placed in the following topic categories:

Anti-Bacterial Agents
Mycoses
Candidiasis
Clotrimazole
Miconazole

Antifungal Agents
Caspofungin
Tioconazole
Micafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Candidiasis
Therapeutic Uses

Antifungal Agents
Caspofungin
Pharmacologic Actions
Micafungin

ClinicalTrials.gov processed this record on May 07, 2009