RecruitingNot ApplicableNCT06755281

Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

Sponsor

Deniz Göcebe

Enrollment

100 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

penicillin allergy Hypersensitivity, Immediate Hypersensitivity, Delayed Hypersensitivity Response

Summary

The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Direct Oral challenge and standard of care for people with hypersensitivity response, hypersensitivity, delayed, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDirect Oral challenge

Patients will receive a 1-step or 2-step challenge with the suspected penicillin and will be monitored for any allergic reaction within the first four hours. Patients will be instructed to contact the hospital after the drug provocation test to inquire delayed allergic reactions.

OTHERstandard of care

The patient will receive skin prick test and patch test (if a delayed allergy is suspected). Allergen-specific IgE will be measured. If all negative, drug provocation tets will be performed identical to the experimental group.