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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02574988
Other study ID # Chula-ARC 001/15
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT01696500 - Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. Phase 3
Terminated NCT02037347 - Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis Phase 1/Phase 2
Withdrawn NCT02319616 - Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis Phase 1/Phase 2
Withdrawn NCT02795143 - Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study N/A
Recruiting NCT06119490 - Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis Early Phase 1
Withdrawn NCT00372723 - Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN) Phase 2
Not yet recruiting NCT03585946 - Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis