Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06755281

Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

Led by Deniz Göcebe · Updated on 2025-04-10

100

Participants Needed

2

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult outpatients or inpatients with a penicillin allergy label
  • Willing and able to give consent
  • PEN-FAST score of 0-2 points
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent
  • Concurrent antihistamine therapy
  • Pregnancy
  • Significantly impaired general condition
  • Unstable or therapeutically inadequately controlled bronchial asthma
  • History of stem cell transplantation
  • History of acute interstitial nephritis
  • Chronic urticaria
  • Mastocytosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University Hospital Heidelberg, Dermatology

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

2

University Hospital Heidelberg, Division of Infectious Diseases and Tropical Medicine

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

Loading map...

Research Team

D

Deniz Göcebe, MD

CONTACT

K

Knut Schäkel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here