Establishment of a Registry for Immediate Drug Allergy

NCT07390370 | Not Yet Recruiting

• 1 other identifier: 4-2025-1428
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Immediate drug hypersensitivity reactions are acute adverse reactions that occur within one hour of drug administration and can result in life-threatening symptoms such as urticaria, angioedema, and anaphylaxis. Current diagnostic methods have high false-negative and false-positive rates, and standardized testing for non-IgE-mediated reactions (e.g., MRGPRX2) is lacking. This creates significant gaps in patient safety and clinical decision-making. The study aims to establish a registry of patients with immediate drug hypersensitivity reactions to analyze clinical characteristics and investigate the underlying mechanisms of IgE-mediated and non-IgE-mediated reactions. Blood samples will be collected prospectively, using residual serum from routine clinical tests where available, to minimize additional blood draws. Mechanistic analyses will focus on IgE-mediated and non-IgE-mediated pathways, including MRGPRX2 expression in mast cells and basophils, and measurement of active β-tryptase as a biomarker for anaphylaxis. In addition, a retrospective review will be conducted of medical records from the last 10 years to identify causative drugs and classify the underlying mechanisms of hypersensitivity. Based on this, specific target drugs will be selected for further prospective analysis. Data and biospecimens from participants in an existing allergy registry, who consent to secondary use, will also be included in the study. Through the integration of clinical data and multi-layered biomarker analysis, the study aims to improve understanding of immediate drug hypersensitivity mechanisms and develop predictive models. Ultimately, this research will contribute to the establishment of personalized diagnosis, prevention, and treatment strategies for drug allergies.

Conditions

Drug Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Endotype Classification and Basophil Activation in Immediate Drug Hypersensitivity

  Derivation and classification of endotype clusters in immediate drug hypersensitivity reactions based on basophil/mast cell activation markers and mediator-release profiles.

  4 years

Secondary Outcomes (1)

• Biomarker Associations with Endotypes and Clinical Phenotypes in Drug Hypersensitivity

  4 years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration.

You may qualify if:

• Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration."
• Utilization of samples and clinical data from patients with immediate drug hypersensitivity who consented to participate in secondary research, registered in the study 'Establishment of a Registry for Identifying Factors Related to Diagnosis, Treatment, and Prognosis in Allergic Disease Patients' (Project Number 4-2013-0397).

You may not qualify if:

• Participants who do not consent to participate in the study."
• Children and adolescents under the age of 19."
• Participants who are unable to read or understand the consent form."

Sponsors & Collaborators

• Yonsei University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Collect whole blood and stool samples

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Central Study Contacts

Kyung Hee Park, P

CONTACT

+82-2-2228-1947; white182@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 15, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 5, 2026

Record last verified: 2026-01