A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
研究概览
简要总结
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.
详细描述
To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Presence of candidemia or invasive candidiasis.
- •Presence of one or more of signs and symptoms of acute fungal infection.
排除标准
- •Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.
- •Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.
研究组 & 干预措施
open label
干预措施: Anidulafungin/Fluconazole (Drug)
结局指标
主要结局
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
时间窗: End of Intravenous Treatment (Up to Day 42)
Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available \[N/A\] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.
次要结局
- Percentage of Participants With Global Response at End of Treatment (EOT)(End of Treatment (Up to Day 42))
- Percentage of Participants With Clinical Response at EOIT(End of Intravenous Treatment (Up to Day 42))
- Percentage of Participants With Clinical Response at EOT(End of Treatment (Up to Day 42))
- Percentage of Participants With Clinical Response at Follow-Up(Post treatment follow-up visit (Up to Day 52))
- Percentage of Participants With Microbiological Response at EOIT(End of Intravenous Treatment (Up to Day 42))
- Percentage of Participants With Microbiological Response at EOT(End of Treatment (Up to Day 42))
- Percentage of Participants With Microbiological Response at Follow-Up(Post treatment follow-up visit (Up to Day 52))
- Number of Participants Who Died(Baseline to Day 52)