Severe Cutaneous Adverse Reactions in Thailand

Chulalongkorn University200 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

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

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

Mortality

Time frame: 1 year

Diagnostic values of in vitro tests for drug allergy diagnosis

Time frame: 1 year

Secondary Outcomes

Complications

Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement

Time frame: 1 year

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

Time frame: 1 year

Central Contacts

Jettanong Klaewsongkram, MD

CONTACT

02-2564152 Jettanong.K@chula.ac.th

Data from ClinicalTrials.gov

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