Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeniz Göcebe

About this trial

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

Qualifiers

Adult outpatients or inpatients with a penicillin allergy label

Willing and able to give consent.

PEN-FAST score of 0-2 points

Disqualifiers

Age <18 years

Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent

Concurrent antihistamine therapy

Pregnancy

Trial design

Treatments tested in this trial

  • Direct Oral challenge
  • standard of care

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Deniz Göcebe

Lead sponsor

University Hospital Heidelberg

Sponsor institution