Support Tool for Antibiotic Allergy deLabeling

ConditionAntibiotic Allergy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hospitalized patients

AAL for one or more beta-lactams

Disqualifiers

Age younger than 18

Previous enrolment in this study

Trial design

Design model

Crossover

Treatments tested in this trial

EPR search
Other intervention
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

Treatment groups

3,000 Participants

are divided into 2 treatment groups

Group A: AAL fact-checkExperimental treatment 1 intervention

Group B: Standard of care (no AAL fact-check)No intervention 0 interventions

Trial outcomes

Primary outcomes

First line antibiotic use: yes (1)/no (0)

First line and/or narrow-spectrum beta-lactam antibiotic use (depending on the index indication, and following the guidelines of the Belgian Antibiotic Policy Coordination Commission BAPCOC), as a binary outcome.

Time frame