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Trial record 11 of 64 for:    Recruiting, Not yet recruiting, Available Studies | Drug allergy

Severe Cutaneous Adverse Reactions in Thailand (ThaiSCAR)

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ClinicalTrials.gov Identifier: NCT02574988
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Chiang Mai University
Thammasat University
Phramongkutklao College of Medicine and Hospital
Mahidol University
Information provided by (Responsible Party):
Jettanong Klaewsongkram, 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

Condition or disease
Steven-Johnson Syndrome Toxic Epidermal Necrolysis Drug Reaction With Eosinophilia and Systemic Symptoms Acute Generalized Exanthematous Pustulosis Generalized Bullous Fixed Drug Eruption

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Multicenter Registry of Patients With Severe Cutaneous Adverse Reactions Among Tertiary Medical Institutes in Thailand
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort
SCAR Patients
Patients diagnosed with severe cutaneous adverse reactions with be recruited



Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
  2. Diagnostic values of in vitro tests for drug allergy diagnosis [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: 1 year ]
    Percentages of patients suffer from severe cutaneous adverse reactions will be reported and categorized according to organ involvement

  2. 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


Biospecimen Retention:   Samples With DNA
cryopreserved peripheral blood mononuclear cells, buffy coat, serum


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574988


Contacts
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Contact: Jettanong Klaewsongkram, MD 02-2564152 Jettanong.K@chula.ac.th

Locations
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Thailand
Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Jettanong Klaewsongkram, MD    662-2564152    Jettanong.K@chula.ac.th   
Principal Investigator: Jettanong Klaewsongkram, MD         
Sponsors and Collaborators
Chulalongkorn University
Chiang Mai University
Thammasat University
Phramongkutklao College of Medicine and Hospital
Mahidol University
Investigators
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Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University

Additional Information:

Publications of Results:

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Responsible Party: Jettanong Klaewsongkram, Jettanong Klaewsongkram, MD., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02574988     History of Changes
Other Study ID Numbers: Chula-ARC 001/15
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jettanong Klaewsongkram, Chulalongkorn University:
drug allergy
drug hypersensitivity
adverse drug reactions
severe cutaneous adverse reactions
Additional relevant MeSH terms:
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Drug Eruptions
Drug Hypersensitivity Syndrome
Drug-Related Side Effects and Adverse Reactions
Drug Hypersensitivity
Hypersensitivity
Stevens-Johnson Syndrome
Eosinophilia
Acute Generalized Exanthematous Pustulosis
Chemically-Induced Disorders
Leukocyte Disorders
Hematologic Diseases
Skin Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Dermatitis
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Immune System Diseases