Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

NCT06755281 NA RECRUITING

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.

Details

Lead sponsor	Deniz Göcebe
Phase	NA
Status	RECRUITING
Enrolment	100
Start date	2025-01-08
Completion	2027-02

Conditions

• Penicillin Allergy
• Hypersensitivity, Immediate
• Hypersensitivity, Delayed
• Hypersensitivity Response

Interventions

• Direct Oral challenge
• standard of care

Primary outcomes

• The difference in the proportion of patients with any positive finding in skin tests, allergen-specific IgE or drug provocation test between the two groups — 7 days
  Percentage of subjects that retain their allergy label as they show at least one positive finding in skin tests, allergen-specific IgE or drug provocation test.

Countries

Germany