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The Diagnosis of Penicillin/Aminopenicillin Allergy in Thailand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01667055
First received: August 15, 2012
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
The true prevalence of drug allergy in patients with a history of penicillin/aminopenicillin allergy will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.

Condition
Penicillin Allergy
Aminopenicillin Allergy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Optimized Diagnostic Methods for the Confirmation of Penicillin/Aminopenicillin Allergy in Thailand

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • The true prevalence of drug allergy in patients with a history of penicillin/aminopenicillin allergy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The skin test positive rate in patients with a history of penicillin/aminopenicillin allergy determined by standard skin test reagents


Secondary Outcome Measures:
  • Clinical values of various diagnostic modalities in patients with a history of penicillin/aminopenicillin allergy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The diagnostic values of skin testing, drug-specific IgE measurement, and interferon-gamma ELISpot assay for the diagnosis of penicillin/aminopenicillin allergy


Biospecimen Retention:   Samples Without DNA
Peripheral blood mononuclear cells in patients with a history of non-immediate reaction

Enrollment: 160
Study Start Date: November 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with suspected drug allergy
Patients with a history of allergic reaction to penicillin/aminopenicillin

Detailed Description:

Patients with a history of penicillin/aminopenicillin allergy will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable).

Diagnostic values of the measurement of specific IgE to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents.

The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.

  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a history of penicillin/aminopenicillin allergy
Criteria

Inclusion Criteria:

  • Patients with a history of penicillin/aminopenicillin allergy

Exclusion Criteria:

  • Being pregnant
  • Having serious medical illnesses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667055

Locations
Thailand
Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University
  More Information

Responsible Party: Jettanong Klaewsongkram, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01667055     History of Changes
Other Study ID Numbers: Chula-ARC 002/12 
Study First Received: August 15, 2012
Last Updated: July 25, 2016
Health Authority: Thailand: Ethical Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Chulalongkorn University:
drug allergy
drug hypersensitivity
beta-lactam allergy
penicillin allergy
adverse drug reaction

Additional relevant MeSH terms:
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 08, 2016