Tool to remove incorrect antibiotic allergy labels in hospitalized adults
Official title: Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement
Run by Universitaire Ziekenhuizen KU Leuven · NCT06771440 · Data updated 2026-11-12
This project will test a non-invasive 'AAL-fact-check' that uses a questionnaire, electronic health record review, and contact with primary care to see if hospitalized adults with a beta-lactam allergy label can have that label removed or refined so doctors can choose better antibiotics.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | December 2025 |
| Study ends | May 2026 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06771440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Hospitalized adults (age 18 or older) who have an antibiotic allergy label for one or more beta-lactams and are treated at a participating site are the intended participants.
✕Probably not a fit
Patients with a recent clear severe immediate allergic reaction to beta-lactams or those with prior confirmed allergy testing are unlikely to have their label removed and may not benefit from this non-invasive approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter interventional project compares a non-invasive AAL-fact-check approach to standard care in hospitalized adults with beta-lactam allergy labels. The approach combines electronic patient record (EPR) searches, a structured questionnaire, and outreach to primary care to clarify or invalidate reported antibiotic allergies without skin or provocation testing. Investigators will measure effects on antibiotic selection, clinical outcomes, antimicrobial use, and economic endpoints. A prior single-center European pilot in 200 patients removed or refined up to half of labels, motivating this broader validation in multiple Belgian hospitals.
Why it matters
Potential benefit: If successful, more patients could safely receive first-line beta-lactam antibiotics, leading to fewer broad-spectrum antibiotic uses, shorter hospital stays, and lower costs.
How similar studies have gone: A prior single-center European implementation of this non-invasive protocol in 200 inpatients removed or refined up to half of antibiotic allergy labels, but multicenter evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Hospitalized patients 2. AAL for one or more beta-lactams Exclusion Criteria: 1. Age younger than 18 2. Previous enrolment in this study
Where it's running
-
University Hospitals Leuven
Leuven, Belgium Recruiting
Study contacts
- Principal investigator: Rik Schrijvers, MD, PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Liesbeth Gilissen, PhD
- Email: liesbeth.gilissen@kuleuven.be
- Phone: +32 16 71 00 84
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.