Severe Cutaneous Adverse Reactions in Thailand

Toxic Epidermal Necrolysis Clinical Trial

— ThaiSCAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574988
• Other study ID #: Chula-ARC 001/15
• Status: Recruiting
• Start date: January 2014
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Chulalongkorn University
• Contact: Jettanong Klaewsongkram, MD
• Phone: 02-2564152
• Email: Jettanong.K[@]chula.ac.th
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Generalized Exanthematous Pustulosis
• Drug Hypersensitivity Syndrome
• Drug Reaction With Eosinophilia and Systemic Symptoms
• Drug-Related Side Effects and Adverse Reactions
• Eosinophilia
• Generalized Bullous Fixed Drug Eruption
• Steven-Johnson Syndrome
• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
Chulalongkorn University	Chiang Mai University, Mahidol University, Phramongkutklao College of Medicine and Hospital, Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Chongpison Y, Rerknimitr P, Hurst C, Mongkolpathumrat P, Palapinyo S, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C, Sukasem C, Tuchinda P, Baiardini I, Klaewso — View Citation

Klaewsongkram J, Sukasem C, Thantiworasit P, Suthumchai N, Rerknimitr P, Tuchinda P, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C; ThaiSCAR study group. Analys — View Citation

Klaewsongkram J, Thantiworasit P, Suthumchai N, Rerknimitr P, Sukasem C, Tuchinda P, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C. In vitro test to confirm dia — View Citation

Suthumchai N, Srinoulprasert Y, Thantiworasit P, Rerknimitr P, Tuchinda P, Chularojanamontri L, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C, Sukasem C, Klaewsongkram J; ThaiSCAR study group. The me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 year
Primary	Diagnostic values of in vitro tests for drug allergy diagnosis		1 year
Secondary	Complications	Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement	1 year
Secondary	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	1 year