The Diagnosis of Beta-lactam Hypersensitivity in Thailand

Completed

• Conditions: Beta Lactam Adverse Reaction; Aminopenicillin Allergy; Penicillin Allergy

• Registration Number: NCT01667055
• Lead Sponsor: Chulalongkorn University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-17
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-27
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with a history of beta-lactam hypersensitivity

Exclusion Criteria

• Being pregnant
• Having serious medical illnesses

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity	1 year	The skin test positive rate in patients with a history of beta-lactam hypersensitivity

Secondary Outcome Measures

Name	Time	Method
Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity	1 year	The diagnostic values of skin testing, drug-specific Immunoglobulin E measurement, and interferon-gamma ELISpot assay for the diagnosis of beta-lactam hypersensitivity

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand