NCT06771440

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 20, 2024

Last Update Submit

December 15, 2025

Conditions

Antibiotic Allergy

Keywords

Penicillin allergyDelabelingbeta-lactamelectronic health recordsclinical decision supportAntibiotic allergydrug allergy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Until 100 days after discharge

Secondary Outcomes (20)

  • Antibiotic allergy label removed: yes (1)/no (0)

    Until 100 days after discharge

  • Antibiotic allergy label refined: yes (1)/no (0)

    Until 100 days after discharge

  • Beta-lactam antibiotic tolerance: yes (1)/no (0)

    Until 100 days after discharge

  • Need to switch antibiotics: yes (1)/no (0)

    Until 100 days after discharge

  • Days until clinical recovery (days)

    Until 14 days after discharge

  • +15 more secondary outcomes

Study Arms (2)

AAL fact-check

EXPERIMENTAL

Semi-automated EPR search for re-exposure

Other: EPR search

Standard of care (no AAL fact-check)

NO INTERVENTION

Interventions

EPR searchOTHER

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

Also known as: AAL-fact-check tool
AAL fact-check

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients
  • AAL for one or more beta-lactams

You may not qualify if:

  • Age younger than 18
  • Previous enrolment in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Rik Schrijvers, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liesbeth Gilissen, PhD

CONTACT

+32 16 71 00 84liesbeth.gilissen@kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Multi-centre open label cross-over cluster-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

January 13, 2025

Study Start

March 10, 2025

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

December 16, 2025

Record last verified: 2024-12

Locations

BE(1)