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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Summary of Global Response at End of Treatment (EOT)
研究概览
简要总结
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.
详细描述
The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.
排除标准
- •Patients with invasive aspergillosis for more than 30 days at the time of study entry. Patients with uncontrolled bacterial or viral infection at the time of study entry. Patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.
研究组 & 干预措施
combination 2
anidulafungin plus voriconazole
干预措施: voriconazole (Drug)
combination 1
anidulafungin plus voriconazole
干预措施: anidulafungin (Drug)
结局指标
主要结局
Summary of Global Response at End of Treatment (EOT)
时间窗: 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.
次要结局
- Summary of Global Response at Week 2, Week 4, and Week 6(Week 2, Week 4, Week 6)
- Summary of Mortality(Up to Week 6)
- Galactomannan Titer Assay Levels and Global Response(Up to Week 6)
- Voriconazole Trough Levels With Intravenous and Oral Dosing(Week 1 through Week 6)