Support Tool for Antibiotic Allergy deLabeling
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EPR search.
- Who it may be relevant to
- Registry conditions: Antibiotic Allergy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement
Overview
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).
Interventions
- Other 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
Primary outcome measures
- First line antibiotic use: yes (1)/no (0) [Time frame: Until 100 days after discharge]
Secondary outcome measures (12)
- Antibiotic allergy label removed: yes (1)/no (0) [Time frame: Until 100 days after discharge]
- Antibiotic allergy label refined: yes (1)/no (0) [Time frame: Until 100 days after discharge]
- Beta-lactam antibiotic tolerance: yes (1)/no (0) [Time frame: Until 100 days after discharge]
- Need to switch antibiotics: yes (1)/no (0) [Time frame: Until 100 days after discharge]
- Days until clinical recovery (days) [Time frame: Until 14 days after discharge]
- In-hospital mortality: yes (1)/no (0) [Time frame: Until 14 days after discharge of discharge/death]
- 3 months post-hospitalization mortality: yes (1)/ no (0) [Time frame: Until 14 days after discharge]
- Length of hospital stay (days) [Time frame: Until 14 days after discharge]
- Admission to ICU: yes (1)/no (0) [Time frame: Until 14 days after discharge]
- Readmission within 3 months after discharge: yes (1)/no (0) [Time frame: Until 100 days after discharge]
- Colonization with MRSA: yes (1)/no (0) [Time frame: Until 100 days after discharge]
- Infection with MRSA: yes (1)/no (0) [Time frame: Until 100 days after discharge]
Eligibility criteria
Inclusion criteria
- Hospitalized patients
- AAL for one or more beta-lactams
Exclusion criteria
- Age younger than 18
- Previous enrolment in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- University Hospitals Leuven — Leuven
Identifiers
NCT: NCT06771440 · S68439