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Change in study design
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine |
| ||
| Intravenous Immunoglobulin |
| ||
| Etanercept |
| ||
| Steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Site specific standard of care comparison | Drug | Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Percent of deaths in each group | 3 years |
| Time to cessation of new lesion formation | Days until no new lesions arise from time of initiation of therapy | 3 years |
| Time to re-epithelialization | Days until skin has completely healed | 3 years |
| Hospital length of stay | Time from hospital admission to discharge | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adults hospitalized with 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.
Data to be recorded includes age, gender, past medical history, medications prior to admission, allergies, physical exam including body sites and surface area involved, pain scores, laboratory values, imaging results, and outcome in terms of morbidity and mortality. The privacy of subjects and their data will be maintained by de-identifying patient data by substituting codes for medical record numbers.
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
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| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064419 | Chemically-Induced Disorders |