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.
Adult outpatients or inpatients with a penicillin allergy label
Willing and able to give consent.
PEN-FAST score of 0-2 points
Age <18 years
Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent
Concurrent antihistamine therapy
Pregnancy
Parallel
Direct Oral challenge
Other interventionPatients 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
Other interventionThe 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.
The difference in the proportion of patients with any positive finding in skin tests, allergen-specific IgE or drug provocation test between the two groups
Percentage of subjects that retain their allergy label as they show at least one positive finding in skin tests, allergen-specific IgE or drug provocation test.
Negative predictive capacity of skin tests and allergen-specific IgE
Negative predictive values of each test alone and combined
Analysis of medical and allergic history
(supposed) allergic symptoms
Penicillin allergy label
Identification of culprit penicillin
Analysis of demographic data
Age, sex
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Deniz Göcebe
Lead sponsor
University Hospital Heidelberg
Sponsor institution
