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Severe Cutaneous Adverse Reactions in Thailand

Conditions
Steven-Johnson Syndrome
Toxic Epidermal Necrolysis
Drug Reaction With Eosinophilia and Systemic Symptoms
Acute Generalized Exanthematous Pustulosis
Generalized 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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mortality1 year
Diagnostic values of in vitro tests for drug allergy diagnosis1 year
Secondary Outcome Measures
NameTimeMethod
Quality of Life1 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

Complications1 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

🇹🇭

Bangkok, Thailand

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