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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 Who Are Intolerant of Polyene Treatment
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.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 6 |
| Start date | 2008-08 |
| Completion | 2009-02 |
Conditions
- Aspergillosis
Interventions
- voriconazole
- anidulafungin
Primary outcomes
- Summary of Global Response at End of Treatment (EOT) — End of Treatment (Day 42)
Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.
Countries
United States