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NCT01667055 Clinical Trial

The Diagnosis of Beta-lactam Hypersensitivity in Thailand

Penicillin Allergy Clinical Trial

Official title:
The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01667055
Other study ID # Chula-ARC 002/12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date December 2018

Study information
Verified date October 2019
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity 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.

Description:

Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics .

Diagnostic values of the measurement of specific Immunoglobulin E 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 7 Years and older
Eligibility Inclusion Criteria:

- Patients with a history of beta-lactam hypersensitivity

Exclusion Criteria:

- Being pregnant

- Having serious medical illnesses

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Chulalongkorn University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity The skin test positive rate in patients with a history of beta-lactam hypersensitivity 1 year
Secondary Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity The diagnostic values of skin testing, drug-specific Immunoglobulin E measurement, and interferon-gamma ELISpot assay for the diagnosis of beta-lactam hypersensitivity 1 year
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