The Diagnosis of Beta-lactam Hypersensitivity in Thailand

NCT ID: NCT01667055

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Penicillin Allergy Aminopenicillin Allergy Beta Lactam Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with suspected drug allergy

Patients with a history of hypersensitivity reaction to beta-lactam antibiotics

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with a history of beta-lactam hypersensitivity

Exclusion Criteria

* Being pregnant
* Having serious medical illnesses
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Assoc. Prof. Jettanong Klaewsongkram, MD.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jettanong Klaewsongkram, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Chongpison Y, Palapinyo S, Mongkolpathumrat P, Buranapraditkun S, Thantiworasit P, Klaewsongkram J. Beta-lactam hypersensitivity diagnosis in ambulatory and hospitalized settings require different approaches. Ann Allergy Asthma Immunol. 2023 Jan;130(1):84-92.e1. doi: 10.1016/j.anai.2022.09.011. Epub 2022 Sep 16.

Reference Type DERIVED
PMID: 36122888 (View on PubMed)

Other Identifiers

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Chula-ARC 002/12

Identifier Type: -

Identifier Source: org_study_id

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