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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
History of Changes

March 7, 2005
June 27, 2008
September 2004
April 2006   (final data collection date for primary outcome measure)
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 ]
Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy
Complete list of historical versions of study NCT00105144 on ClinicalTrials.gov Archive Site
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 ]
Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy
 
 
 
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Candidiasis
  • Candidemia
  • Drug: Micafungin
    IV
    Other Names:
    • Mycamine
    • FK463
  • Drug: Caspofungin
    IV
    Other Name: Cancidas
  • Experimental: 1
    lower dose
    Intervention: Drug: Micafungin
  • Experimental: 2
    higher dose
    Intervention: Drug: Micafungin
  • Active Comparator: 3
    Intervention: Drug: Caspofungin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
611
April 2006
April 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Brazil,   Canada,   Croatia,   Czech Republic,   France,   Germany,   India,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00105144
03-0-192
No
Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc
Astellas Pharma Inc
 
Study Director: Central Contact Astellas Pharma US, Inc.
Astellas Pharma Inc
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP