NCT01306773已完成不适用
Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
详细描述
Patients presented with severe 2009 H1N1 infection responded poorly to antiviral agents. Meta-analysis of reports from 1918 H1N1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 H1N1 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin
- •laboratory confirmatory diagnosis of 2009 H1N1 infection by positive RT-PCR from respiratory specimens
- •required intensive care within 7 days of onset of symptoms
排除标准
- •age 18 years old or below
- •known hypersensitivity to immune globulin
- •known IgA deficiency
研究组 & 干预措施
H1N1 convalescent plasma and oseltamivir
Active Comparator
Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma
干预措施: H1N1 convalescent plasma and oseltamivir (Drug)
Oral Oseltamivir alone
Active Comparator
Oseltamivir 75mg bid during ICU hospitalization
干预措施: Oral Oseltamivir alone (Drug)
结局指标
主要结局
Death
时间窗: Participants are followed until death or discharge from ICU (average 2 weeks)
mortality during hospitalization directly related to H1N1 2009 infection
次要结局
- Complication(Participants are followed until death or discharge from ICU (average 2 weeks))
- Length of stay in ICU(Participants are followed until death or discharge from ICU (average 2 weeks))
- Adverse events secondary to the convalescent plasma treatment(Participants are followed until death or discharge from ICU (average 2 weeks))
- Time on respiratory support(Participants are followed until death or discharge from ICU (average 2 weeks))
- Change in viral load(Participants are followed until death or discharge from ICU (average 2 weeks))
- Change in cytokine level(Participants are followed until death or discharge from ICU (average 2 weeks))
研究者
研究点 (1)
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