Testing for safe removal of penicillin allergy labels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to validate the safety and negative predictive capacity of direct drug provocation tests for patients with self-reported penicillin allergies who are classified as low-risk using the PEN-FAST score. Participants with a PEN-FAST score of 0-2 will undergo a drug challenge without prior skin testing, allowing researchers to assess the safety of this approach compared to standard testing methods. The study will monitor participants for immediate and delayed allergic reactions following the drug provocation tests. The outcomes will help determine the effectiveness of the PEN-FAST score in identifying patients who can safely tolerate penicillin.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Heidelberg, Dermatology
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine
  Heidelberg, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Deniz Göcebe, MD
• Email: Deniz.Goecebe@med.uni-heidelberg.de
• Phone: +4962215639539

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nurse-and-allergist provocation pathway for penicillin allergy delabelling (PANDA)

  This project will try a nurse-and-allergist team approach to remove incorrect penicillin allergy labels in patients treated at participating hospitals, and compare it to the usual allergist-only pathway.

  Recruiting at 4 sites The University of Hong Kong · Hong Kong and 3 other locations · NCT07127835

• Testing a single versus double dose of amoxicillin for penicillin allergy delabeling

  This study tests whether giving one dose of amoxicillin is just as safe and effective as giving two doses for adults who have been labeled as penicillin-allergic but are considered low-risk.

  Recruiting Phase 3 Texas Tech University Health Sciences Center · Lubbock, Texas · NCT06303128

• Understanding anti-drug antibodies causing hypersensitivity during anesthesia

  This study is trying to find out if certain antibodies in patients can help identify those at risk for severe allergic reactions to anesthesia drugs during surgery.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Paris · NCT05420935

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.