Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Absence rate of IFDs assessed by physical examination and serum galactomannan test
研究概览
简要总结
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
详细描述
The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after Autologous hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation
- •Under 21 years old, pediatric, adolescent patients.
排除标准
- •Aspartate transaminase or alanine transaminase level > 5 times UNL
- •Bilirubin > 2.5 times UNL
- •History of allergy, sensitivity, or any serious reaction to an echinocandin
- •Invasive fungal disease at the time of enrolment
- •Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
- •Positive pregnancy test
研究组 & 干预措施
Micafungin
干预措施: micafungin (Drug)
结局指标
主要结局
Absence rate of IFDs assessed by physical examination and serum galactomannan test
时间窗: 4 weeks
Absence of proven, probable, possible invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of Micafungin prophyalxis after HSCT
次要结局
- Survival rate(100 days)
- Safety assessed by lab-test and adverse events(4 weeks)