A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Subjects With Global Response of Success at End of Treatment
研究概览
简要总结
The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.
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
- •Subjects with at least one positive blood test for Candida pathogen from a blood sample taken within 96 hours prior to start of study treatment.
- •Subjects with clinical evidence of candida infection within 48 hours prior to enrollment.
- •Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20.
排除标准
- •Prior exposure to systemic antifungals for more than 48 hours.
- •Subjects who had, at any time, previously received anidulafungin.
- •Subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples.
- •Life expectancy < 72 hours.
研究组 & 干预措施
Open
This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.
干预措施: Anidulafungin (Drug)
结局指标
主要结局
Number of Subjects With Global Response of Success at End of Treatment
时间窗: End of treatment (EOT) = Day 5 up to Day 42
Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species \[spp\]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.
次要结局
- Number of Subjects With Global Response of Success at Endpoints(End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline))
- Number of Subjects With Clinical Response of Success at Endpoints(EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline)
- Number of Subjects With Microbiological Response of Success at Endpoints(EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline)
- Time to Death From Any Cause(Baseline through end of 12 weeks after baseline)
- Time to Death Due to Candidemia(Baseline through end of 12 weeks after baseline)
- Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment(Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42))
- Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment(Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42))
- Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment(Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42))
- Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT(Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42))
- Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups(EOT (Day 5 up to Day 42))