Severe Cutaneous Adverse Reactions in Thailand

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

Sponsors

Lead Sponsor: Chulalongkorn University

Collaborator: Chiang Mai University
Thammasat University
Phramongkutklao College of Medicine and Hospital
Mahidol University

Source Chulalongkorn University
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

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

Overall Status Unknown status
Start Date 2014-01-01
Completion Date 2020-12-01
Primary Completion Date 2020-12-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Mortality 1 year
Diagnostic values of in vitro tests for drug allergy diagnosis 1 year
Secondary Outcome
Measure Time Frame
Complications 1 year
Quality of Life 1 year
Enrollment 200
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

15 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jettanong Klaewsongkram, MD Principal Investigator Chulalongkorn University
Overall Contact

Last Name: Jettanong Klaewsongkram, MD

Phone: 02-2564152

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Faculty of Medicine, Chulalongkorn University Jettanong Klaewsongkram, MD 662-2564152 [email protected] Jettanong Klaewsongkram, MD Principal Investigator
Location Countries

Thailand

Verification Date

2019-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chulalongkorn University

Investigator Full Name: Jettanong Klaewsongkram

Investigator Title: Jettanong Klaewsongkram, MD.

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: SCAR Patients

Description: Patients diagnosed with severe cutaneous adverse reactions with be recruited

Acronym ThaiSCAR
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News