SUMMARY OF THE ACTIVE SJS/TEN STUDIES AT VANDERBILT

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  1. North American Therapeutics In Epidermal Necrolysis Syndrome Study:

NATIENS is a clinical trial for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis patients in the acute stage. This study aims to determine if two therapeutic treatments– cyclosporine and etanercept– are effective in improving the short-term outcomes of SJS/TEN compared to the typical standard of care.

 

The study is open to SJS/TEN patients who are 18 years and older and in the acute stage of SJS/TEN. Registration will open in the fall of 2021 and is limited to 267 participants. The studies will be done at Vanderbilt.

 

https://clinicaltrials.gov/ct2/show/NCT02987257

 

  1. SJS Survivor Study:

The purpose of this study is to look at the genetic basis and long-term consequences of SJS/TEN in diverse populations. Vanderbilt is doing genetic typing on DNA samples collected from SJS survivors who have had drug-induced SJS. In addition, Vanderbilt is analyzing questionnaires pertaining to the health of SJS survivors to perform qualitative assessments–interviews, focus groups and observations–of health in a select group of survivors.

 

This study is for SJS/TEN survivors in the United States, ages 7 to 90 years old.

 

https://www.dropbox.com/s/85hcune07gr156p/Stamped-SurvivorflyerQRS_11.09.2020.pdf?dl=0

 

Registration: 

 

https://redcap.vanderbilt.edu/surveys/?s=WDKRMTR9J9

 

  1. SJS/TEN Associated with Anti-Tuberculous and HIV Drugs:

Vanderbilt is conducting a study on the prediction and prevention of SJS/TEN caused by Anti-Tuberculous and HIV Drugs in South Africa.

 

  1. Rapid Point of Care Testing for SJS/TEN:

Vanderbilt is looking for rapid point of care markers–markers that indicate the possibility of allergic reactions–that could be used to predict and prevent SJS/TEN at the point of care for drugs like Nevirapine in South Africa.

 

  1. SJS/TEN in Vanderbilt BioVu:

Vanderbilt is looking at ways to determine SJS/TEN by analyzing electronic health records to find SJS/TEN cases that were misdiagnosed and is also pulling DNA samples to help develop our understanding of the genetic basis of SJS/TEN. This research aims to find non-identified cases of SJS/TEN and to provide patients with proper post SJS/TEN treatment.

 

  1. Laboratory Based Studies:

Vanderbilt is looking at assays–lab tests that determine the presence of a substance–in their laboratory to identify which drugs were the cause of SJS/TEN. These assays are called ELISpot assays and they look at specific cytokine release–a protein that is released during a reaction– in the presence of potentially implicated drugs to develop a diagnostic assay. This diagnostic assay is a lab test that determines the cause of SJS/TEN.

 

  1. Laboratory-based Studies to Determine Mechanisms of SJS/TEN:

Vanderbilt is conducting studies that look at the blister fluid and skin from patients with SJS/TEN to determine specific signs that occur in the presence of certain medications. These tests also aim to analyze if your DNA predisposes you to a particular reaction to a drug. The goal of these tests is to make predicting which drugs may cause SJS/TEN easier and determining if a patient has SJS/TEN at the first sign of reaction. Often in the pre-marketing phase of drug development, there are not enough patients who have developed SJS to gather this information on a population basis, so developing tests that can determine this in an individual would be huge for SJS/TEN prevention and treatment.

 

 

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