Health Trials

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

Locations

2
University Hospital Heidelberg, Dermatology69120, HeidelbergBaden-Wurttemberg, Germany
University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine69120, HeidelbergBaden-Wurttemberg, Germany

Sponsors and collaborators

Deniz Göcebe

Lead sponsor

University Hospital Heidelberg

Sponsor institution

Source ClinicalTrials.gov