The Diagnosis of Beta-lactam Hypersensitivity in Thailand

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01667055

Enrollment

500

Registered

2012-08-17

Start date

2012-06-30

Completion date

2018-12-31

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aminopenicillin Allergy, Beta Lactam Adverse Reaction, Penicillin Allergy

Keywords

drug allergy, drug hypersensitivity, beta-lactam allergy, penicillin allergy, adverse drug reaction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

7 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a history of beta-lactam hypersensitivity

Exclusion criteria

* Being pregnant * Having serious medical illnesses

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Thailand

Outcome results