Testing for safe removal of penicillin allergy labels
Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels
NA · University Hospital Heidelberg · NCT06755281
This study is testing if a new way to check if people with low-risk penicillin allergies can safely take penicillin without needing skin tests.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Locations | 2 sites (Heidelberg, Baden-Wurttemberg and 1 other locations) |
| Trial ID | NCT06755281 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients with a penicillin allergy label and a PEN-FAST score of 0-2.
Not a fit: Patients under 18 years old, those on immunosuppressive therapy, or with significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more efficient methods for removing unnecessary penicillin allergy labels, improving treatment options for patients.
How similar studies have performed: While some studies have questioned the PEN-FAST score's predictive capacity, this approach of direct drug provocation testing without prior skin testing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg, Baden-Wurttemberg and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Penicillin Allergy, Hypersensitivity, Immediate, Hypersensitivity, Delayed, Hypersensitivity Response, PEN-FAST, penicillin allergy, allergy delabeling