Actively Recruiting
Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
Led by Deniz Göcebe · Updated on 2025-04-10
100
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult outpatients or inpatients with a penicillin allergy label
- Willing and able to give consent
- PEN-FAST score of 0-2 points
You will not qualify if you...
- Age under 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital Heidelberg, Dermatology
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
Research Team
D
Deniz Göcebe, MD
CONTACT
K
Knut Schäkel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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