NCT02686853Unknown4 期
Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Without Acquired Immune Deficiency Syndrome
Hui Bu0 个研究点目标入组 40 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 主要终点
- laboratory examination of cerebrospinal fluid
研究概览
简要总结
The main purpose of this study is to observe the clinical effect of intrathecal administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune Deficiency Syndrome (AIDS).
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cryptococcus neoformans are found in CSF
排除标准
- •Patients with serious heart, lung, liver and renal insufficiency.
- •Patients who took broad-spectrum antibiotics and corticosteroids for a long-term.
- •Patients with AIDS or obvious immunodeficiency.
- •Patients with long term dialysis or intravenous catheter.
- •Patients with other brain organic disease such as purulent meningitis, intracranial swelling, etc.
研究组 & 干预措施
Intrathecal administration group
Experimental
干预措施: Liposomal amphotericin B (Drug)
结局指标
主要结局
laboratory examination of cerebrospinal fluid
时间窗: 2 to 4 weeks
It includes routine test，biochemistry indicators and cytology ，namely white blood cell count per litre， protein（in g/l），glucose（in mmol/l）and chloride（in mmol/l）in cerebrospinal fluid ，an assessment will be assessed every week
次要结局
- changes of clinical symptoms(2 to 4 weeks)
研究者
Hui Bu
Study Principal Investigator
Hebei Medical University
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