Support Tool for Antibiotic Allergy deLabeling (STAAL)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Antibiotic Allergy

Treatments: Other: EPR search

Study type: Interventional

Funder types: Other

Identifiers

NCT06771440

S68439

Details and patient eligibility

About

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).

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

3,000 participants in 2 patient groups

AAL fact-check

Experimental group

Description:

Semi-automated EPR search for re-exposure

Treatment:

Other: EPR search

Standard of care (no AAL fact-check)

No Intervention group