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临床试验/NCT03585946
NCT03585946撤回不适用

A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Massachusetts General Hospital0 个研究点目标入组 750 人开始时间: 2030年1月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Kroshinsky

Associate Professor of Dermatology

Massachusetts General Hospital

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