Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Global Treatment Response Success at End of Treatment
研究概览
简要总结
To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.
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
- •ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
- •Post-abdominal surgery.
- •Elderly > 65 years old.
- •Renal insufficiency / failure / hemodialysis.
- •Solid tumor.
- •Solid-organ (liver, kidney, lung, heart) transplant recipients.
- •Hepatic insufficiency.
- •Neutropenic including hematology oncology patients.
排除标准
- •Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.
研究组 & 干预措施
Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
干预措施: Anidulafungin (Drug)
Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
干预措施: Fluconazole (Drug)
Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
干预措施: Voriconazole (Drug)
结局指标
主要结局
Percentage of Participants With Global Treatment Response Success at End of Treatment
时间窗: End of Treatment (Day 14 to Day 56)
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
次要结局
- Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)(EOIVT (Day 10 up to Day 42))
- Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment(2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14))
- Percentage of Participants With Global Response Success 6 Weeks After End of Treatment(6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42))
- Time to First Negative Blood Culture(Day 1 up to Day 42)
- Day 90 Survival(Day 90)
- Time to Successful Intensive Care Unit (ICU) Discharge(Day 1 up to Day 56)