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Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

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ClinicalTrials.gov Identifier: NCT00105144
Recruitment Status : Completed
First Posted : March 8, 2005
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Candidiasis Candidemia Drug: Micafungin Drug: Caspofungin Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105144


Locations
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Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Central Contact Astellas Pharma US, Inc.
More Information
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Additional Information:

Publications:

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

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00105144    
Obsolete Identifiers: NCT00235742
Other Study ID Numbers: 03-0-192
First Posted: March 8, 2005    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Treatment Effectiveness
Treatment Efficacy
Investigational, Therapies
 Antifungal, Systemic
Antibiotics, Antifungal
Micafungin
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Bacterial Infections and Mycoses
Infections
Invasive Fungal Infections
Fungemia
Sepsis
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Caspofungin
Micafungin
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action