The Diagnosis of Beta-lactam Hypersensitivity in Thailand

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Penicillin Allergy Aminopenicillin Allergy Beta Lactam Adverse Reaction Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chulalongkorn University

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a history of beta-lactam hypersensitivity

Exclusion criteria

Being pregnant
Having serious medical illnesses

Treatment and study plan

Primary outcomes

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

Time frame: 1 year

The skin test positive rate in patients with a history of beta-lactam hypersensitivity

Secondary outcomes

Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity

Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Aug 17, 2012
Registry last updated: Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed