NCT00372723撤回2 期
Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
Loyola University0 个研究点开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- 30 day mortality
研究概览
简要总结
To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.
详细描述
This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.
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
- 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
- •Admission to burn unit with a histologic diagnosis of TENs
排除标准
- •Pregnancy
- •hypersensitivity to remicaide
- •history of heart failure
- •documented bacteremia
- •history of cancer
- •inability to consent
结局指标
主要结局
30 day mortality
时间窗: 30 days
次要结局
- Safety labs and adverse events(30 days)
研究者
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