Severe Cutaneous Adverse Reactions in Thailand

NCT ID: NCT02574988

Last Updated: 2019-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SCAR Patients

Patients diagnosed with severe cutaneous adverse reactions with be recruited

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Jettanong Klaewsongkram

Jettanong Klaewsongkram, MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jettanong Klaewsongkram, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Jettanong Klaewsongkram, MD

Role: CONTACT

02-2564152

Facility Contacts

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Jettanong Klaewsongkram, MD

Role: primary

662-2564152

References

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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.

Reference Type RESULT
PMID: 29800753 (View on PubMed)

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.

Reference Type RESULT
PMID: 29478292 (View on PubMed)

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.

Reference Type RESULT
PMID: 27106261 (View on PubMed)

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.

Reference Type RESULT
PMID: 30346532 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37678574 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34734507 (View on PubMed)

Other Identifiers

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Chula-ARC 001/15

Identifier Type: -

Identifier Source: org_study_id

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