Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- in hospital all cause morality
研究概览
简要总结
The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 15 years old
- •admitted to intensive care unit
- •proven or strong suspicion of H1N1 Influenza infection
- •diffuse pneumonia (for less than 96 hours)
- •need for non invasive or invasive mechanical ventilation
排除标准
- •pregnancy
- •an age of 15 or less
- •rapidly fatal underlying disease with a life expectancy of one month or less
- •more than 3 organ dysfunction upon admission
- •previous treatment with corticosteroids (ie prednisone 30 mg per day or more, or equivalent, for at least one month)
- •formal indication for corticosteroids (eg Addison disease, status asthmaticus)
- •already on corticosteroids for 2 days or more in the management of the current episode
- •acute lung injury not related to viral pneumonia
- •presence of H1N1 related acute myocarditis or encephalitis
- •receiving antiviral treatment for more than 5 days
研究组 & 干预措施
Corticosteroids
Hydrocortisone
干预措施: hydrocortisone (Drug)
Control
isotonic saline
干预措施: isotonic saline (Drug)
结局指标
主要结局
in hospital all cause morality
时间窗: hospital discharge up to 90 days
次要结局
- 6 month all cause mortality(180 days)
- intensive care unit free days(hospital discharge up to 90 days)
- proportion of patients with secondary infections(hospital discharge up to 90 days)
- mechanical ventilation free days(hospital discharge up to 90 days)
- proportion of patients who require ECMO(hospital discharge up to 90 days)
- 90 day all cause mortality(90 day)
- 28 day mortality(28 day)
- respiratory function and health status(180 days)
研究者
Djillali Annane
Dean of the health Science Centre
University of Versailles