Tool to remove incorrect antibiotic allergy labels in hospitalized adults
Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06771440 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leuven
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.