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Antibiotic AllergySTAALNCT06771440

Support Tool for Antibiotic Allergy deLabeling

A study testing EPR search in people with Antibiotic Allergy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Antibiotic Allergy
What is being tested?
EPR search
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteBelgium
Study dates
10 Mar 2025to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age younger than 18
  • Previous enrolment in this study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liesbeth Gilissen, PhD contact

+32 16 71 00 84

liesbeth.gilissen@kuleuven.be

Belgium1 site, 1 recruiting

  • University Hospitals Leuven

    Leuven

    Rik Schrijvers, rik.schrijvers@uzleuven.be

    Liesbeth Gilissen, liesbeth.gilissen@kuleuven.be

    Recruiting

Other trials in Belgium

About this study

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

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).

Being tested
EPR search
Keywords
Penicillin allergy, Delabeling, beta-lactam, electronic health records, clinical decision support, Antibiotic allergy, drug allergy
Medical subject headings
Drug Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPR searchOther

    Also called AAL-fact-check tool

    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

Study groups in NCT06771440
Study groupRoleWhat they receive
AAL fact-checkExperimentalSemi-automated EPR search for re-exposure
Receives: Other: EPR search
Standard of care (no AAL fact-check)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Until 100 days after discharge

Secondary outcomes (20)

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

  5. Days until clinical recovery (days)

    Measured: Until 14 days after discharge

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

    Measured: Until 14 days after discharge of discharge/death

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

    Measured: Until 14 days after discharge

  8. Length of hospital stay (days)

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

    Measured: Until 14 days after discharge

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

    Measured: Until 14 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

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

    Measured: Until 100 days after discharge

  17. Cost of antibiotic treatment (euro)

    Measured: Until 14 days after discharge

  18. Cost of hospitalization (euro)

    Measured: Until 14 days after discharge

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

    AAL fact-check procedure will be timed by the investigator

    Measured: Until 14 days after discharge

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

    Measured: Until 14 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start10 Mar 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Model description
Multi-centre open label cross-over cluster-randomized controlled trial
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06771440
Sponsor's protocol ID
S68439
Acronym
STAAL
Status last verified
Dec 2024
First submitted
20 Dec 2024
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gilissen L, Van De Sijpe G, Spriet I, Schrijvers R. Impact Assessment of the Allergy Fact Checker, a Clinical Decision Support Tool for Noninvasive Beta-Lactam Antibiotic Allergy Label Delabeling: Protocol for a Multicenter Crossover Cluster-Controlled Study. JMIR Res Protoc. 2026 Mar 27;15:e86056. doi: 10.2196/86056.

    PubMed 41894402

Questions about this trial

What is this clinical trial studying?

A study testing EPR search in people with Antibiotic Allergy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liesbeth Gilissen, PhD (+32 16 71 00 84, liesbeth.gilissen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First line antibiotic use: yes (1)/no (0) (time frame: Until 100 days after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06771440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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