Severe Cutaneous Adverse Reactions in Thailand

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Brief Title

Severe Cutaneous Adverse Reactions in Thailand

Official Title

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

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
    


Study Type

Observational [Patient Registry]


Primary Outcome

Mortality

Secondary Outcome

 Complications

Condition

Steven-Johnson Syndrome


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

200

Start Date

January 2014

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility 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

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jettanong Klaewsongkram, MD, 02-2564152, [email protected]

Location Countries

Thailand

Location Countries

Thailand

Administrative Informations


NCT ID

NCT02574988

Organization ID

Chula-ARC 001/15


Responsible Party

Principal Investigator

Study Sponsor

Chulalongkorn University

Collaborators

 Chiang Mai University

Study Sponsor

Jettanong Klaewsongkram, MD, Principal Investigator, Chulalongkorn University


Verification Date

February 2019