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Search / Trial NCT06755281

Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

Launched by DENIZ GÖCEBE · Dec 22, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pen Fast Penicillin Allergy Allergy Delabeling

ClinConnect Summary

This clinical trial is looking at how safe it is to remove penicillin allergy labels from patients who believe they are allergic to penicillin. The study focuses on patients who report having immediate or delayed allergic reactions to penicillin but are considered low-risk based on a specific scoring system called the PEN-FAST score. Those eligible for the trial are adults who have a penicillin allergy label and score between 0 to 2 points on the PEN-FAST scale. Participants will undergo a direct test with the medication instead of the usual skin tests to see if they can safely take penicillin.

If you or a family member are interested in participating, you need to be an adult with a penicillin allergy label and be able to provide consent. However, there are certain conditions that would exclude someone from joining, such as being under 18 years old, being pregnant, or having specific health issues. The trial is currently recruiting participants, and those who join can expect to be closely monitored during the testing process to ensure their safety. This study aims to better understand how to identify patients who can safely use penicillin again, potentially improving their treatment options.

Gender

ALL

Eligibility criteria

  • 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

About Deniz Göcebe

Deniz Göcebe is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes. With a focus on innovative therapies and a rigorous approach to clinical development, Deniz Göcebe collaborates with healthcare professionals and research institutions to design and implement trials that adhere to the highest ethical and scientific standards. The organization prioritizes patient safety and data integrity while fostering a culture of transparency and collaboration, ultimately aiming to contribute valuable insights to the medical community and enhance treatment options for various health conditions.

Locations

Heidelberg, Baden Württemberg, Germany

Heidelberg, Baden Württemberg, Germany

Heidelberg, , Germany

Heidelberg, , Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported