NCT06771440

Support Tool for Antibiotic Allergy deLabeling

Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Antibiotic allergy labels (AAL) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of AAL, i.e., prevalence of 6%). They are associated with increased length of hospital stay, and use of second-line and broad-spectrum antibiotics. Allergy workups are able to invalidate the majority of these AAL but are time-consuming and require invasive skin and provocation testing. The investigators recently evaluated, for the first time in Europa, a strictly non-invasive delabeling protocol using a questionnaire, medical file search and contact with primary care health care workers in 200 adult internal medicine inpatients with a beta-lactam AAL. Up to half of the AAL could be removed or refined, demonstrating the potential of this strategy. In this project, they aim to assess the impact of using the non-invasive 'AAL-fact-check' tool in a multicenter study, on antibiotic selection, and clinical, antimicrobial, and economic endpoints, as compared with the standard of care (i.e., no AAL-fact-check tool).

Conditions

• Antibiotic Allergy

Interventions

Type	Name	Description
OTHER	EPR search	A stored query in the EPR, that checks for re-exposure to the culprit antibiotic or class-member, from the date of AAL registration to the date of patient inclusion

Timeline

• Start date: 2025-03-10
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2025-01-13
• Last updated: 2025-12-16

Locations

1 site across 1 country: Belgium