Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 17, 2025
Date Accepted: Feb 19, 2026
Impact assessment of the allergy fact checker, a clinical decision support tool for non-invasive beta-lactam antibiotic allergy label delabeling: Protocol paper for a multicenter cross-over cluster-controlled study.
ABSTRACT
Background:
Beta-lactam allergy labels (BLALs), especially penicillin allergy labels, are frequently recorded in hospitalized patients and are associated with increased use of broad-spectrum and second-line antibiotics. Most BLALs are incorrect, but current allergy workups require invasive testing and specialized resources. We recently developed a strictly non-invasive, electronic patient record (EPR)-embedded clinical decision support tool, the “Allergy fact checker” (AFC), which proactively identifies potentially incorrect BLALs by detecting uneventful re-exposure(s) to the culprit or other beta-lactams since introduction of the BLAL.
Objective:
This study aims to evaluate the clinical, antimicrobial, and economic impact of the AFC in hospitalized adults with BLALs compared to the standard of care (no AFC).
Methods:
We are conducting a multicenter, open-label, 3-period, cross-over cluster-controlled study in 9 hospitals in Flanders, Belgium. All hospitalized adults with a BLAL are eligible, excluding patients in palliative care, discharged within 24 hours, or previously enrolled. Each hospital will alternate between intervention (use of the AFC) and control (standard practice) phases, separated by washout periods. The primary endpoint is the appropriate prescription of first-line and/or narrow-spectrum beta-lactams according to Belgian Antibiotic Policy Coordination Commission guidelines (IGGI). Secondary endpoints include delabeling/refinement rate, beta-lactam tolerance, antibiotic switching, hospital length of stay, in-hospital and 3-month mortality, intensive care unit (ICU) admission, readmission, multidrug-resistant organism colonization/infection, and costs. Based on prior data, we calculated that with at least 6 clusters and an expected inclusion rate of 78 subjects per period, we will have 80% power to detect superiority of the intervention (4.6% vs 9.9% appropriate prescribing). Recruitment started in March 2025 and is ongoing.
Results:
The primary outcome will be analyzed using hierarchical models accounting for intra- and intercluster correlation. Data collection will continue until 200 days after the last patient is discharged. The trial is expected to conclude in 2026.
Conclusions:
This is the first multicenter European study evaluating a strictly non-invasive BLAL delabeling approach. If successful, this AFC tool could improve antimicrobial stewardship, reduce costs, and provide a scalable model for centralized allergy label management. Clinical Trial: ClinicalTrials.gov NCT06771440; https://clinicaltrials.gov/study/NCT06771440
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