Toxic Epidermal Necrolysis Clinical Trial
— ThaiSCAROfficial title:
The Multicenter Registry of Patients With Severe Cutaneous Adverse Reactions Among Tertiary Medical Institutes in Thailand
The multicenter registry of patients with severe cutaneous adverse reactions among tertiary medical institutes in Thailand to study clinical characteristics, etiologies, therapeutic outcomes, quality of life, and the values of in vitro drug allergy diagnosis for the confirmation of the causative drugs
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - Patients fulfilled criteria of probable or definite cases of SJS, TEN, DRESS, or AGEP according to RegiSCAR validation criteria as well as patients diagnosed with GBFDE Exclusion Criteria: - Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Chulalongkorn University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University | Chiang Mai University, Mahidol University, Phramongkutklao College of Medicine and Hospital, Thammasat University |
Thailand,
Chongpison Y, Rerknimitr P, Hurst C, Mongkolpathumrat P, Palapinyo S, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C, Sukasem C, Tuchinda P, Baiardini I, Klaewso — View Citation
Klaewsongkram J, Sukasem C, Thantiworasit P, Suthumchai N, Rerknimitr P, Tuchinda P, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C; ThaiSCAR study group. Analys — View Citation
Klaewsongkram J, Thantiworasit P, Suthumchai N, Rerknimitr P, Sukasem C, Tuchinda P, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C. In vitro test to confirm dia — View Citation
Suthumchai N, Srinoulprasert Y, Thantiworasit P, Rerknimitr P, Tuchinda P, Chularojanamontri L, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C, Sukasem C, Klaewsongkram J; ThaiSCAR study group. The me — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | 1 year | ||
Primary | Diagnostic values of in vitro tests for drug allergy diagnosis | 1 year | ||
Secondary | Complications | Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement | 1 year | |
Secondary | Quality of Life | Patient's quality of life will be assessed by using The World Health Organization Quality of Life (WHOQOL)-BREF; Thai version and The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q); Thai version | 1 year |
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