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Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis
The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 282 |
| Start date | 2007-07 |
| Completion | 2010-06 |
Conditions
- Candidiasis
Interventions
- Eraxis (anidulafungin)
- Diflucan (fluconazole)
- Vfend (voriconazole)
Primary outcomes
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) — End of Treatment (Day 5 up to Day 42)
Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species \[spp\]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Countries
United States, South Korea