Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03585946

Collaborator

(none)

750

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Drug Reaction	Drug: Site specific standard of care comparison

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cyclosporine	Drug: Site 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.
Intravenous Immunoglobulin	Drug: Site 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.
Etanercept	Drug: Site 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.
Steroids	Drug: Site 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.

Outcome Measures

Primary Outcome Measures

Mortality [3 years]
Percent of deaths in each group
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniela Kroshinsky, Associate Professor of Dermatology, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT03585946

Other Study ID Numbers:

P201700P002792

First Posted:

Jul 13, 2018

Last Update Posted:

Dec 2, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Stevens-Johnson Syndrome

Syndrome

Study Results

No Results Posted as of Dec 2, 2020