Clinical trial NCT06771440: Support Tool for Antibiotic Allergy DeLabeling
Official title: Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Antibiotic Allergy
Keywords: Penicillin allergy
Delabeling
beta-lactam
electronic health records
clinical decision support
Antibiotic allergy
drug allergy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Noorderhart Pelt
name: AZ Herentals
name: Heilig Hartziekenhuis, Mol
name: AZ Turnhout
name: Sint-Jozefskliniek Izegem
First posted: 2025-01-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multi-centre open label cross-over cluster-randomized controlled trial
Primary purpose: DIAGNOSTIC

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

Primary outcomes:
measure: First line antibiotic use: yes (1)/no (0)
timeFrame: Until 100 days after discharge
Secondary outcomes:
measure: Antibiotic allergy label removed: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Antibiotic allergy label refined: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Beta-lactam antibiotic tolerance: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Need to switch antibiotics: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Days until clinical recovery (days)
timeFrame: Until 14 days after discharge
measure: In-hospital mortality: yes (1)/no (0)
timeFrame: Until 14 days after discharge of discharge/death
measure: 3 months post-hospitalization mortality: yes (1)/ no (0)
timeFrame: Until 14 days after discharge
measure: Length of hospital stay (days)
timeFrame: Until 14 days after discharge
measure: Admission to ICU: yes (1)/no (0)
timeFrame: Until 14 days after discharge
measure: Readmission within 3 months after discharge: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Colonization with MRSA: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Infection with MRSA: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Colonization with VRE: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Infection with VRE: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Colonization with C.Diff: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Infection with C.Diff: yes (1)/no (0)
timeFrame: Until 100 days after discharge
measure: Cost of antibiotic treatment (euro)
timeFrame: Until 14 days after discharge
measure: Cost of hospitalization (euro)
timeFrame: Until 14 days after discharge
measure: Time needed to perform the AAL fact-check (minutes)
timeFrame: Until 14 days after discharge
measure: Cost of human resources needed for AAL-fact-check (euro)
timeFrame: Until 14 days after discharge
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Rik Schrijvers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: