NCT07194824

A Penicillin Allergy Delabeling Inhospital Model Hospitalized Patients

Design, Implementation and Analysis of a Penicillin Allergy Delabeling Model in Hospitalized Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Design, implementation and analysis of an allergy assessment and management model beta-lactams in hospitalized patients

Detailed description

To evaluate the impact of a healthcare process for risk stratification based on the clinical history and the application of a structured questionnaire, on the Proportion of hospitalized patients in whom the penicillin allergy label is removed

Conditions

• Allergy Drug
• Allergy Penicillin

Interventions

Type	Name	Description
OTHER	Pragmatic allergy management according to risk stratification	Intervention based on allergy risk stratification. Tipus A) Patients in this group can undergo direct delabeling without the need for exposure, with this being documented in the EMR. If the patient refuses, an exposure to penicillin and/or cephalosporin will be performed. Once completed, de-labeling can proceed without the need for re-exposure. Tipus B) Indication for use of a penicillin: Oral exposure to 250 mg of amoxicillin. \- Indication for cephalosporin : administration of a cephalosporin that exhibits the lowest level of cross-reactivity with penicillin. Re-exposure to penicillin/ cephalosporin or both is performed at least 2 weeks after the first tolerated exposure. De-labeling is performed when tolerance to re-exposure is verified. Tipus C) These high-risk patients are managed following the protocol for the treatment of patients with beta-lactam allergy, referring them to allergy consultation for further specific test.

Timeline

• Start date: 2024-04-04
• Primary completion: 2025-05-23
• Completion: 2025-05-25
• First posted: 2025-09-26
• Last updated: 2026-01-13

Locations

2 sites across 1 country: Spain