NCT02646774终止4 期
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 43
- 主要终点
- Overall success rate for patients with no hematology disease
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG
- •Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study.
- •Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
排除标准
- •Patient received any echinocandins drug within 1 month prior to enrollment.
- •Patient was enrolled in any other clinical study within the last month.
- •AST/ALT > 5 times the upper limit of normal (ULN)
- •total bilirubin> 2.5 times ULN
- •BUN/Ccr > 3 times ULN
- •HIV positive patient
- •Patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
- •Patient has a life expectancy of <1 month
- •Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
- •Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study.
- •Patient has been previously enrolled in this study.
研究组 & 干预措施
Micafungin group
Experimental
Injection
干预措施: Micafungin (Drug)
结局指标
主要结局
Overall success rate for patients with no hematology disease
时间窗: At the end of the treatment (up to a maximum of 4 weeks)
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Overall success rate for patients with hematology disease
时间窗: At the end of the treatment (up to a maximum of 12 weeks)
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
次要结局
- Clinical Improvement rate for patients with hematology disease(Week 1 up to the end of the treatment (up to a maximum of 12 weeks))
- Clinical improvement rate for patients with no hematology disease(Week 1 up to the end of the treatment (up to a maximum of 4 weeks))
- Fungal clearance rate for patients with no hematology disease(Week 1 up to the end of the treatment (up to a maximum of 4 weeks))
- Fungal clearance rate for patients with hematology disease(Week 1 up to the end of the treatment (up to a maximum of 12 weeks))
- Fatality rate for patients with no hematology disease(End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients))
- Fatality rate for patients with hematology disease(End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients))
- Percentage of participants with common Aspergillus infection sites(End of treatment (up to 12 weeks))
- Safety assessed by adverse events(Up to 2 weeks after end of treatment (up to14 weeks))
研究者
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