Steven-Johnson SyndromeThaiSCARNCT02574988
Severe Cutaneous Adverse Reactions in Thailand
An observational study of Steven-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Chulalongkorn University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Steven-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction With Eosinophilia and Systemic Symptoms
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Jettanong Klaewsongkram, MD, 662-2564152, Jettanong.K@chula.ac.th
Jettanong Klaewsongkram, MD
About this study
Official title: The Multicenter Registry of Patients With Severe Cutaneous Adverse Reactions Among Tertiary Medical Institutes in Thailand
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
Read the 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
- 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
- Medical subject headings
- Stevens-Johnson Syndrome, Drug Hypersensitivity Syndrome, Acute Generalized Exanthematous Pustulosis, Drug Hypersensitivity, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCAR Patients | Patients diagnosed with severe cutaneous adverse reactions with be recruited |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 year
Diagnostic values of in vitro tests for drug allergy diagnosis
Measured: 1 year
Secondary outcomes (2)
Complications
Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Steven-Johnson SyndromeStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University, Thammasat University, Phramongkutklao College of Medicine and Hospital, Mahidol University
- Responsible party
- Principal investigator, Jettanong Klaewsongkram, Chulalongkorn University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574988
- Sponsor's protocol ID
- Chula-ARC 001/15
- Acronym
- ThaiSCAR
- Status last verified
- Feb 2019
- First submitted
- 12 Oct 2015
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29800753Suthumchai 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.
PubMed 29478292Klaewsongkram 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.
PubMed 27106261Chongpison 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.
PubMed 30346532Chongpison 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.
PubMed 37678574Klaewsongkram 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.
PubMed 34734507
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multicenter Registry of Patients With Severe Cutaneous Adverse Reactions Among Tertiary Medical Institutes in Thailand
- ClinicalTrials.gov ID
- NCT02574988
- Acronym / sponsor ID
- ThaiSCAR / Chula-ARC 001/15
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Chiang Mai University, Thammasat University, Phramongkutklao College of Medicine and Hospital, Mahidol University
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCAR Patients | – | –Patients diagnosed with severe cutaneous adverse reactions with be recruited |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients later confirmed to have other diagnosis than diseases mentioned above or have no sufficient data for the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 1 year
Diagnostic values of in vitro tests for drug allergy diagnosis
Time frame: 1 year
2 secondary outcomes
Complications
Time frame: 1 year
Quality of Life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Results publication: PubMed 29800753Klaewsongkram 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.
- Results publication: PubMed 29478292Suthumchai 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.
- Results publication: PubMed 27106261Klaewsongkram 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.
- Results publication: PubMed 30346532Chongpison 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.
- Derived from this study: PubMed 37678574Chongpison 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.
- Derived from this study: PubMed 34734507Klaewsongkram 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jettanong Klaewsongkram, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steven-Johnson Syndrome and Toxic Epidermal Necrolysis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jettanong Klaewsongkram, MD (02-2564152, Jettanong.K@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574988, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.