The Diagnosis of Penicillin/Aminopenicillin Allergy in Thailand

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01667055
First received: August 15, 2012
Last updated: March 11, 2014
Last verified: March 2014
  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 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:
  • The diagnostic values of currently used skin test reagents and drug-specific IgE measurement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The sensitivity of currently used skin test reagents in Thailand and penicilloyl/amoxicilloyl-specific IgE compared to the standard skin test reagents for the diagnosis of penicillin/aminopenicillin allergy


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with suspected drug allergy
Patients with a history of an immediate reaction to penicillin or aminopenicillin allergy

Detailed Description:

Patients with a history of an immediate reaction to penicillin/aminopenicillin 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.

  Eligibility

Ages Eligible for Study:   7 Years and older
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 an immediate reaction to penicillin/aminopenicillin

Exclusion Criteria:

  • Being pregnant
  • Having serious medical illnesses
  • Have a history of severe non-immediate reaction to penicillin/aminopenicillin
  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

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

Locations
Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Jettanong Klaewsongkram, MD    02-2564152    Jettanong.K@chula.ac.th   
Principal Investigator: Jettanong Klaewsongkram, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University
  More Information

No publications provided

Responsible Party: Jettanong Klaewsongkram, Assistant 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: March 11, 2014
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on September 18, 2014