A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 750
- 主要终点
- Time to re-epithelialization
研究概览
简要总结
This is a prospective, multicenter cohort observational; study to compare treatment outcomes in patients admitted to the hospital with Stevens-Johnsons Syndrome/Toxic Epidermolysis, aiming to assess the utility of medical management. The hypothesis of this study is that one or more treatment options will demonstrate improved patient outcomes. The primary objectives are cessation of progression of disease, time to complete re-epithelialization, length of stay, and mortality rate in the treatment groups as compared to those receiving supportive care alone. Exploratory analyses will assess the cause, risk factors, and severity prediction factors associated with the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a diagnosis of Stevens Johnsons Syndrome/Toxic Epidermal Necrolysis confirmed by examination of a dermatologist and/or skin biopsy plus described appropriate clinical findings (epidermal necrosis plus two involved mucosal surfaces) presenting within one week of disease onset
排除标准
- •Pregnancy
- •Age <18y
- •Decisional impairment
- •Incarceration
- •Onset of skin separation >7d
研究组 & 干预措施
Cyclosporine
干预措施: Site specific standard of care comparison (Drug)
Intravenous Immunoglobulin
干预措施: Site specific standard of care comparison (Drug)
Etanercept
干预措施: Site specific standard of care comparison (Drug)
Steroids
干预措施: Site specific standard of care comparison (Drug)
结局指标
主要结局
Time to re-epithelialization
时间窗: 3 years
Days until skin has completely healed
Hospital length of stay
时间窗: 3 years
Time from hospital admission to discharge
Mortality
时间窗: 3 years
Percent of deaths in each group
Time to cessation of new lesion formation
时间窗: 3 years
Days until no new lesions arise from time of initiation of therapy
次要结局
未报告次要终点
研究者
Daniela Kroshinsky
Associate Professor of Dermatology
Massachusetts General Hospital
