Drug Reaction, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Conditions
Brief summary
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.
Interventions
DRUGSite specific standard of care comparison
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.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Pregnancy * Age \<18y * Decisional impairment * Incarceration * Onset of skin separation \>7d
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to cessation of new lesion formation | 3 years | Days until no new lesions arise from time of initiation of therapy |
| Time to re-epithelialization | 3 years | Days until skin has completely healed |
| Hospital length of stay | 3 years | Time from hospital admission to discharge |
| Mortality | 3 years | Percent of deaths in each group |
Outcome results
None listed