Clinical Trial: Severe Cutaneous Adverse Reactions in Thailand

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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 Summary: 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
Sponsor: Chulalongkorn University

Current Primary Outcome: Mortality [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complications [ Time Frame: 1 year ]
    Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement
  • Quality of Life [ Time Frame: 1 year ]
    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


Original Secondary Outcome:

  • Complications [ Time Frame: 1 year ]
  • Quality of Life [ Time Frame: 1 year ]


Information By: Chulalongkorn University

Dates:
Date Received: October 12, 2015
Date Started: January 2014
Date Completion: December 2017
Last Updated: July 25, 2016
Last Verified: July 2016