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Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
Sponsor: Deniz Göcebe
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-01-08
Completion Date
2027-02
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
Direct 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.
standard 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.
Locations (2)
University Hospital Heidelberg, Dermatology
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine
Heidelberg, Baden-Wurttemberg, Germany