Severe Cutaneous Adverse Reactions in Thailand
- Conditions
- Steven-Johnson SyndromeToxic Epidermal NecrolysisDrug Reaction With Eosinophilia and Systemic SymptomsAcute Generalized Exanthematous PustulosisGeneralized Bullous Fixed Drug Eruption
- Registration Number
- NCT02574988
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
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
- Detailed Description
Patients with severe cutaneous adverse reactions (Steven-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, and generalized bullous fixed drug eruption) among six tertiary medical institutes in Thailand will be recruited to study clinical characteristics, etiologies, therapeutic outcomes, quality of life, and the values of using laboratory techniques for the confirmation of the causative drugs
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 1 year Diagnostic values of in vitro tests for drug allergy diagnosis 1 year
- Secondary Outcome Measures
Name Time Method Quality of Life 1 year 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
Complications 1 year Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement
Trial Locations
- Locations (1)
Faculty of Medicine, Chulalongkorn University
🇹ðŸ‡Bangkok, Thailand