Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Time for healing
研究概览
简要总结
NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.
Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.
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
- Single (Participant)
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
- •Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission
排除标准
- •Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
- •Hypercoagulable state
- •Cardiac or peripheral arterial disease
- •Active malignancy
- •Myelodysplastic syndrome or hematological malignancy
- •Fructose intolerance
- •Pregnancy
- •Patient refusal
研究组 & 干预措施
G-CSF
An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
干预措施: recombinant granulocyte - colony stimulating factor (Drug)
Placebo
An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Time for healing
时间窗: From date of randomization until the date of complete healing, assessed up to 30 days.
Time for complete cutaneous healing, considered as healing of 90% of the body surface area
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
时间窗: At admission and at day 5
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Biological data: Neutrophilic count
时间窗: Every day during the 14th first days
Neutrophilic count
次要结局
- Biological data: WBC count(3 months after discharge)
- Biological data: WBC formula(3 months after discharge)
研究者
Anne-Françoise Rousseau
MD, PhD
University of Liege