Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

Last updated: April 9, 2025
Sponsor: Deniz Göcebe
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy (Pediatric)

Contact Dermatitis

Allergies & Asthma

Treatment

Direct Oral challenge

standard of care

Clinical Study ID

NCT06755281
S-656/2024
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Age <18 years

  2. Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroidequivalent

  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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Direct Oral challenge
Phase:
Study Start date:
January 08, 2025
Estimated Completion Date:
February 28, 2027

Study Description

The PEN-FAST clinical decision rule is an internationally validated scoring system (0-5 points) that identifies low-risk patients (= a score of 0-2 points) with self-reported penicillin allergies with a negative predictive value (NPV) of over 95%. Performing direct drug provocation tests without prior skin testing on these low-risk patients was shown to be non-inferior in terms of safety and prediction of immediate allergic reactions. However, several studies have questioned the negative predictive capacity of the PEN-FAST score. In these studies, misclassifications of the PEN-FAST score were mainly based on positive skin test findings that can show false-positive results.

This study aims to validate the NPV and safety of direct drug provocation tests using the PEN-FAST score.

Participants with a PEN-FAST score of 0-2 points will directly receive a two-dose challenge (50%-50%) or single challenge (100%) with the culprit penicillin and will be monitored for at least 4 hours. No skin tests will be performed prior to the drug provocation test. Patients will be instructed to contact the hospital after the drug provocation test to monitor any delayed allergic reactions.

The outcomes will be compared to those of patients with a PEN-FAST score of 0-2 points who do not wish to skip the skin tests and who will, in parallel, receive the standard-of-care testing.

Currently, this study is approved as a single-site study.

Connect with a study center

  • University Hospital Heidelberg, Dermatology

    Heidelberg, Baden-Württemberg 69120
    Germany

    Active - Recruiting

  • University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine

    Heidelberg, Baden-Württemberg 69120
    Germany

    Active - Recruiting

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