The Diagnosis of Penicillin/Aminopenicillin Allergy in Thailand
This study is currently recruiting participants.
Verified February 2013 by Chulalongkorn University
Sponsor:
Chulalongkorn University
Collaborators:
Prince of Songkla University
Mahidol University
Queen Sirikit National Institute of Child Health
Thammasat University
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01667055
First received: August 15, 2012
Last updated: February 4, 2013
Last verified: February 2013
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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: | 250 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | September 2013 (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
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
Prince of Songkla University
Mahidol University
Queen Sirikit National Institute of Child Health
Thammasat 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: | February 4, 2013 |
| 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 |
ClinicalTrials.gov processed this record on May 16, 2013