Prospective, Observational and Cohort Clinical Research on Clinical Efficacy and Safety of Different Doses of Micafungin Sodium for Injection in Prevention and Treatment of Fungal Infection in Patients With Hematological Tumors
试验速览
- 阶段
- 4 期
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- clinical efficacy
研究概览
简要总结
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.
详细描述
This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. During the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.All subjects were monitored for efficacy and safety according to the visit plan during the research.
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
- •Age ≥ 18 years old, male or female
- •Patients with hematological tumors
- •Neutropenia: The absolute neutrophils count (ANC) in peripheral blood was 0.5×109/L or was expected to be ANC<0.5×109/L 48 hours later.
- •Fever: single measurement of oral temperature ≥ 38.3℃ (axillary temperature ≥ 38.0℃) or oral temperature ≥ 38.0℃ (axillary temperature ≥ 37.7℃) lasts for more than 1h
- •Patients with high risk factors of IFD (Invasive Fungal Disease), such as patients treated with allo-HSCT, patients with acute leukemia (including MDS) undergoing primary induction or rescue chemotherapy, patients with expected granulocytosis lasting more than 10 days, patients with severe granulocytosis or patients with severe aplastic anemia receiving antithymic globulin (ATG) therapy or HSCT therapy, etc.
排除标准
- •The patient is being treated with an antifungal drug
- •People who are known or suspected to be allergic to echinocandins
- •The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis.
- •Existing drug sensitivity results suggest that patients resistant to micafungin
- •Severe chronic liver disease with Child-Pugh grade C
- •Fever caused by tumor
- •Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective
- •Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not.
- •Patients who were not considered suitable for the research
研究组 & 干预措施
High dose group
micafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip
干预措施: Micafungin Sodium (Drug)
结局指标
主要结局
clinical efficacy
时间窗: 14 days
Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin
次要结局
- Survival rate(30 days)
- Safety assessed by lab-test and adverse events(30 days)
研究者
Wang Xin
Director of Department of Hematology
Shandong Provincial Hospital