Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00105144
First received: March 7, 2005
Last updated: June 27, 2008
Last verified: June 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 July 10, 2014