ThaiSCAR: Severe Cutaneous Adverse Reactions in Thailand

Sponsor

Chulalongkorn University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02574988

Collaborator

Chiang Mai University (Other), Thammasat University (Other), Phramongkutklao College of Medicine and Hospital (Other), Mahidol University (Other)

200

Enrollment

Location

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Steven-Johnson Syndrome Toxic Epidermal Necrolysis Drug Reaction With Eosinophilia and Systemic Symptoms Acute Generalized Exanthematous Pustulosis Generalized Bullous Fixed Drug Eruption

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Multicenter Registry of Patients With Severe Cutaneous Adverse Reactions Among Tertiary Medical Institutes in Thailand

Actual Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
SCAR Patients Patients diagnosed with severe cutaneous adverse reactions with be recruited

Outcome Measures

Primary Outcome Measures

Mortality [1 year]
Diagnostic values of in vitro tests for drug allergy diagnosis [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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