Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
Recruiting now · Not applicable
Conditions studied: Penicillin Allergy, Hypersensitivity, Immediate, Hypersensitivity, Delayed, Hypersensitivity Response
In brief
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 facts
- Study ID
- NCT06755281
- Run by
- Deniz Göcebe
- People needed
- 100
- Starts
- 2025-01-08
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2025-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult outpatients or inpatients with a penicillin allergy label
- Willing and able to give consent.
- PEN-FAST score of 0-2 points
You may not qualify if…
- 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
Where it is running
- University Hospital Heidelberg, Dermatology — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
- University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
Full record on ClinicalTrials.gov
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