Severe Cutaneous Adverse Reactions in Thailand

NCT02574988 | Unknown DMC

• 1 other identifier: Chula-ARC 001/15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

drug allergy; drug hypersensitivity; adverse drug reactions; severe cutaneous adverse reactions

Outcome Measures

Primary Outcomes (2)

• Mortality

  1 year

• Diagnostic values of in vitro tests for drug allergy diagnosis

  1 year

Secondary Outcomes (2)

• Complications

  1 year

• Quality of Life

  1 year

Study Arms (1)

SCAR Patients

Patients diagnosed with severe cutaneous adverse reactions with be recruited

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), or generalized bullous fixed drug eruption (GBFDE) from 6 tertiary medical centers in Thailand with be recruited into this registry

You may qualify if:

• 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

You may not qualify if:

• Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry

Sponsors & Collaborators

• Chulalongkorn University: lead
• Chiang Mai University: collaborator
• Thammasat University: collaborator
• Phramongkutklao College of Medicine and Hospital: collaborator
• Mahidol University: collaborator

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

Related Publications (6)

• 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. Analysis of HLA-B Allelic Variation and IFN-gamma ELISpot Responses in Patients with Severe Cutaneous Adverse Reactions Associated with Drugs. J Allergy Clin Immunol Pract. 2019 Jan;7(1):219-227.e4. doi: 10.1016/j.jaip.2018.05.004. Epub 2018 May 22.

  PMID: 29800753 RESULT

• 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 measurement of drug-induced interferon gamma-releasing cells and lymphocyte proliferation in severe cutaneous adverse reactions. J Eur Acad Dermatol Venereol. 2018 Jun;32(6):992-998. doi: 10.1111/jdv.14890. Epub 2018 Mar 13.

  PMID: 29478292 RESULT

• 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 diagnosis of allopurinol-induced severe cutaneous adverse reactions. Br J Dermatol. 2016 Nov;175(5):994-1002. doi: 10.1111/bjd.14701. Epub 2016 Aug 29.

  PMID: 27106261 RESULT

• 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, Klaewsongkram J. Reliability and validity of the Thai Drug Hypersensitivity Quality of Life Questionnaire: a multi-center study. Int J Qual Health Care. 2019 Aug 1;31(7):527-534. doi: 10.1093/intqhc/mzy207.

  PMID: 30346532 RESULT

• Chongpison Y, Sriswasdi S, Buranapraditkun S, Thantiworasit P, Rerknimitr P, Mongkolpathumrat P, Chularojanamontri L, Srinoulprasert Y, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C, Sukasem C, Tuchinda P, Pongcharoen P, Klaewsongkram J. IFN-gamma ELISpot-enabled machine learning for culprit drug identification in nonimmediate drug hypersensitivity. J Allergy Clin Immunol. 2024 Jan;153(1):193-202. doi: 10.1016/j.jaci.2023.08.026. Epub 2023 Sep 9.

  PMID: 37678574 DERIVED

• Klaewsongkram J, Buranapraditkun S, Thantiworasit P, Rerknimitr P, Tuchinda P, Chularojanamontri L, Rerkpattanapipat T, Chanprapaph K, Disphanurat W, Chakkavittumrong P, Tovanabutra N, Srisuttiyakorn C, Srinoulprasert Y, Sukasem C, Chongpison Y. The Role of In Vitro Detection of Drug-Specific Mediator-Releasing Cells to Diagnose Different Phenotypes of Severe Cutaneous Adverse Reactions. Allergy Asthma Immunol Res. 2021 Nov;13(6):896-907. doi: 10.4168/aair.2021.13.6.896.

  PMID: 34734507 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

cryopreserved peripheral blood mononuclear cells, buffy coat, serum

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Drug Hypersensitivity Syndrome; Acute Generalized Exanthematous Pustulosis; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Chemically-Induced Disorders

Study Officials

• Jettanong Klaewsongkram, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jettanong Klaewsongkram, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jettanong Klaewsongkram, MD.

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 14, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)