Acute Generalized Exanthematous Pustulosis, Drug Reaction With Eosinophilia and Systemic Symptoms, Generalized Bullous Fixed Drug Eruption, Steven-Johnson Syndrome, Toxic Epidermal Necrolysis
Conditions
Keywords
drug allergy, drug hypersensitivity, adverse drug reactions, severe cutaneous adverse reactions
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
Interventions
None listed
Sponsors
Chiang Mai University
Thammasat University
Phramongkutklao College of Medicine and Hospital
Mahidol University
Chulalongkorn University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | 1 year |
| Diagnostic values of in vitro tests for drug allergy diagnosis | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 1 year | Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement |
| 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 |
Countries
Thailand
Contacts
Primary ContactJettanong Klaewsongkram, MD
Outcome results
None listed