NCT06771440 Support Tool for Antibiotic Allergy deLabeling
| NCT ID | NCT06771440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Antibiotic Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,000 participants in total. It began in 2025-03-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Rik Schrijvers, MD, PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06771440 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Antibiotic Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06771440 currently recruiting?
Yes, NCT06771440 is actively recruiting participants. Contact the research team at liesbeth.gilissen@kuleuven.be for enrollment information.
Where is the NCT06771440 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06771440 clinical trial?
NCT06771440 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Rik Schrijvers, MD, PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 3,000 participants.