NCT04728971尚未招募4 期
To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 200 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Post-transplant infections
研究概览
简要总结
To evaluate the clinical success rate of micafungin in preventing invasive mycosis after liver transplantation.
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form voluntarily;
- •Liver transplant patients with 1 high-risk factor; A. Transplant again; B. Fulminant liver failure; C. Renal failure requires alternative treatment (defined as creatinine clearance ≤40 ml/min); D. ICU duration before liver transplantation≥48h; E. Have received abdominal surgery within one month before liver transplantation or; F. Common bile duct jejunostomy (except for children); G. Excessive blood transfusion (blood transfusion exceeds 2000mL); H. The donor's ICU hospital stay exceeds 5 days; I. Positive sputum and blood culture of the donor J. The donor has evidence of lung or bloodstream infection (pulmonary infection is evaluated according to the diagnostic criteria and treatment principles (draft) of invasive lung fungal infection, and bloodstream infection is evaluated according to invasive fungal disease of patients with hematopathy/malignant tumor Diagnostic criteria and treatment principles (fifth revised edition) for evaluation) K. 60 years old ≤ age ≤ 65 years old
排除标准
- •Have used other investigational drugs or are participating in other clinical trials within 4 weeks before enrollment;
- •Currently combined with any kind of fungal infection;
- •Allergic to study drugs;
- •Joint transplantation;
- •Women who are pregnant, preparing to become pregnant or breast-feeding;
- •The investigator thinks that it is not suitable to use the test drug.
研究组 & 干预措施
Micafungin Preventing Group
Experimental
干预措施: Micafungin Sodium 50 MG Injection (Drug)
Others Preventing Group
Active Comparator
干预措施: Caspofungin Acetate (Drug)
结局指标
主要结局
Post-transplant infections
时间窗: 90 days
Frequency of clinically or microbiologically documented infection after transplantation.
次要结局
未报告次要终点
研究者
Lin Zhong
Director of Hepatobiliary and Pancreatic Surgery
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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