Clinical Trial: Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multicentre, Prospective, Randomized Open-label Pilot Study to Assess the Feasibility and Preliminary Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of

Brief Summary: The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia

Detailed Summary:
Sponsor: Radboud University

Current Primary Outcome: the time to negative blood cultures [ Time Frame: at fixed time points during follow up (at least until 8 weeks after end of treatment) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • overall survival [ Time Frame: until 8 weeks after end of treatment ]
  • time to death [ Time Frame: Until 8 weeks after end of treatment ]
  • outcome of fungal infection [ Time Frame: Until 8 weeks after end of treatment ]
    resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters
  • duration of antifungal therapy [ Time Frame: Until end of treatment ]
  • duration of hospitalization [ Time Frame: Until end of hospitilization ]
  • immunological parameters [ Time Frame: Until 8 weeks after end of treatment ]
  • tolerability and safety [ Time Frame: until 8 weeks after end of treatment ]


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: January 4, 2011
Date Started: January 2011
Date Completion:
Last Updated: February 13, 2012
Last Verified: February 2012