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Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis

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ClinicalTrials.gov Identifier: NCT03585946
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Daniela Kroshinsky, Massachusetts General Hospital

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
Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Drug Reaction Drug: Site specific standard of care comparison

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Study Type : Observational
Estimated 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021


Group/Cohort 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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 3 years ]
    Percent of deaths in each group

  2. Time to cessation of new lesion formation [ Time Frame: 3 years ]
    Days until no new lesions arise from time of initiation of therapy

  3. Time to re-epithelialization [ Time Frame: 3 years ]
    Days until skin has completely healed

  4. Hospital length of stay [ Time Frame: 3 years ]
    Time from hospital admission to discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

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Responsible Party: Daniela Kroshinsky, Associate Professor of Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03585946     History of Changes
Other Study ID Numbers: P201700P002792
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Syndrome
Drug-Related Side Effects and Adverse Reactions
Stevens-Johnson Syndrome
Disease
Pathologic Processes
Chemically-Induced Disorders
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases