Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
Deniz Göcebe
100 participants
Jan 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Adult outpatients or inpatients with a penicillin allergy label
- Willing and able to give consent.
- PEN-FAST score of 0-2 points
Exclusion Criteria10
- Age <18 years
- Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent
- Concurrent antihistamine therapy
- Pregnancy
- Significantly impaired general condition
- Unstable or therapeutically inadequately controlled bronchial asthma
- History of stem cell transplantation
- History of acute interstitial nephritis
- Chronic urticaria
- Mastocytosis
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT06755281