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Support Tool for Antibiotic Allergy deLabeling

NCT ID: NCT06771440

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2026-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Antibiotic Allergy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Multi-centre open label cross-over cluster-randomized controlled trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AAL fact-check

Semi-automated EPR search for re-exposure

Group Type EXPERIMENTAL

EPR search

Intervention Type OTHER

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

Standard of care (no AAL fact-check)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EPR search

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

Intervention Type OTHER

Other Intervention Names

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AAL-fact-check tool

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Noorderhart Pelt

OTHER

Sponsor Role collaborator

AZ Herentals

UNKNOWN

Sponsor Role collaborator

Heilig Hartziekenhuis, Mol

UNKNOWN

Sponsor Role collaborator

AZ Turnhout

OTHER

Sponsor Role collaborator

Sint-Jozefskliniek Izegem

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rik Schrijvers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Liesbeth Gilissen, PhD

Role: CONTACT

[email protected]
+32 16 71 00 84

Facility Contacts

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Rik Schrijvers

Role: primary

[email protected]

Liesbeth Gilissen

Role: backup

[email protected]

Other Identifiers

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S68439

Identifier Type: -

Identifier Source: org_study_id