Clinical Trial: Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)

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

Official Title: Phase IV Open-Label Pilot Study to Evaluate the Combination of Voriconazole and Anidulafungin for the Treatment of Subjects With Proven or Probable Invasive Aspergillosis

Brief Summary: This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

Detailed Summary: February 8, 2008
Sponsor: Pfizer

Current Primary Outcome: Summary of Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Day 42) ]

Original Primary Outcome: The primary endpoint will be global response consisting of a combination of clinical and radiological findings at the end of therapy. [ Time Frame: up to 6 weeks ]

Current Secondary Outcome:

  • Summary of Global Response at Week 2, Week 4, and Week 6 [ Time Frame: Week 2, Week 4, Week 6 ]
  • Summary of Mortality [ Time Frame: Up to Week 6 ]
  • Galactomannan Titer Assay Levels and Global Response [ Time Frame: Up to Week 6 ]
  • Voriconazole Trough Levels With Intravenous and Oral Dosing [ Time Frame: Week 1 through Week 6 ]


Original Secondary Outcome:

  • To evaluate the safety and tolerability of combination therapy with voriconazole and anidulafungin. [ Time Frame: Up to 6 weeks ]
  • To compare galactomannan titers (an immunological test performed on blood serum) with the Global Response. [ Time Frame: Up to 6 weeks ]
  • To assess voriconazole levels with IV and oral dosing [ Time Frame: Up to 6 weeks ]
  • To evaluate mortality and global response at Weeks 2, 4, 6. [ Time Frame: Up to 6 weeks ]


Information By: Pfizer

Dates:
Date Received: February 8, 2008
Date Started: August 2008
Date Completion:
Last Updated: January 21, 2010
Last Verified: January 2010