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NCT Number: NCT06771440

Support Tool for Antibiotic Allergy deLabeling

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).

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Key information

Conditions

Antibiotic Allergy Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Belgium

Location status: Recruiting

Location contact

Dries Wets

SUB_INVESTIGATOR

Liesbeth Gilissen

CONTACT

[email protected]

Liesbeth Gilissen

SUB_INVESTIGATOR

Rik Schrijvers

CONTACT

[email protected]

Rik Schrijvers

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age younger than 18
  • Previous enrolment in this study

Treatment and study plan

EPR search

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

Other names: AAL-fact-check tool

Primary outcomes

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

    Time frame: Until 100 days after discharge

    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.

Secondary outcomes

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

    Time frame: Until 100 days after discharge

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

    Time frame: Until 100 days after discharge

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

    Time frame: Until 100 days after discharge

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

    Time frame: Until 100 days after discharge

  5. Days until clinical recovery (days)

    Time frame: Until 14 days after discharge

  6. In-hospital mortality: yes (1)/no (0)

    Time frame: Until 14 days after discharge of discharge/death

  7. 3 months post-hospitalization mortality: yes (1)/ no (0)

    Time frame: Until 14 days after discharge

  8. Length of hospital stay (days)

    Time frame: Until 14 days after discharge

    Calculated as (date of discharge) - (date of admission) + 1

  9. Admission to ICU: yes (1)/no (0)

    Time frame: Until 14 days after discharge

  10. Readmission within 3 months after discharge: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  11. Colonization with MRSA: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  12. Infection with MRSA: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  13. Colonization with VRE: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  14. Infection with VRE: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  15. Colonization with C.Diff: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  16. Infection with C.Diff: yes (1)/no (0)

    Time frame: Until 100 days after discharge

  17. Cost of antibiotic treatment (euro)

    Time frame: Until 14 days after discharge

  18. Cost of hospitalization (euro)

    Time frame: Until 14 days after discharge

  19. Time needed to perform the AAL fact-check (minutes)

    Time frame: Until 14 days after discharge

    AAL fact-check procedure will be timed by the investigator

  20. Cost of human resources needed for AAL-fact-check (euro)

    Time frame: Until 14 days after discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Liesbeth Gilissen, PhD

CONTACT

[email protected]

+32 16 71 00 84

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Herentals
  • AZ Turnhout
  • Heilig Hartziekenhuis, Mol
  • Noorderhart Pelt
  • Sint-Jozefskliniek Izegem

Registry information

Official study title

Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement

Acronym: STAAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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