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Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

RecruitingNAAges 18 Years - anyAllDeniz Göcebe
NCT06755281 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult outpatients or inpatients with a penicillin allergy label 2. Willing and able to give consent. 3. PEN-FAST score of 0-2 points Exclusion Criteria: 1. Age \<18 years 2. Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent 3. Concurrent antihistamine therapy 4. Pregnancy 5. Significantly impaired general condition 6. Unstable or therapeutically inadequately controlled bronchial asthma 7. History of stem cell transplantation 8. History of acute interstitial nephritis 9. Chronic urticaria 10. Mastocytosis
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What it tests

  • Direct Oral challenge
  • standard of care
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Where

2 sites
University Hospital Heidelberg, Dermatology
Heidelberg, Germany
University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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