Clinical Trial: Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-center, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Brief Summary: The objective of this study is to evaluate the safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.

Detailed Summary:
Sponsor: Astellas Pharma China, Inc.

Current Primary Outcome:

  • Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis [ Time Frame: Up to a maximum of 10 weeks ]
  • Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis [ Time Frame: Up to a maximum of 14 weeks ]
  • Safety as assessed by adverse reactions for patients with candidiasis [ Time Frame: Up to a maximum of 10 weeks ]
  • Safety as assessed by adverse reactions for patients with aspergillosis [ Time Frame: Up to a maximum of 14 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall success rate for patients with candidiasis [ Time Frame: End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) ]
    Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
  • Overall success rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) ]
    Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
  • Clinical Improvement rate for patients with candidiasis [ Time Frame: End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis ]
  • Clinical Improvement rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) ]
  • Fungal clearance rate for patients with candidiasis [ Time Frame: End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) ]
  • Fungal clearance rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients ]
  • Fatality rate for patients with candidiasis [ Time Frame: End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) ]
  • Fatality rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients ]
  • Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis [ Time Frame: Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) ]
  • Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis [ Time Frame: Day 1 to the end of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) ]
  • Safety as assessed by liver and kidney function for patients with candidiasis [ Time Frame: Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) ]
  • Safety as assessed by liver and kidney function for patients with aspergillosis [ Time Frame: Day 1 to the end of treatment (up to 6 weeks, and up to 8 weeks, and up to 12 weeks for refractory patients) ]


Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: December 16, 2015
Date Started: March 2014
Date Completion:
Last Updated: February 18, 2016
Last Verified: February 2016