Support Tool for Antibiotic Allergy DeLabeling

Not Applicable

Not yet recruiting

• Conditions: Antibiotic Allergy

• Registration Number: NCT06771440
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
First line antibiotic use: yes (1)/no (0)	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 Outcome Measures

Name	Time	Method
Need to switch antibiotics: yes (1)/no (0)	Until 100 days after discharge
Days until clinical recovery (days)	Until 14 days after discharge
In-hospital mortality: yes (1)/no (0)	Until 14 days after discharge of discharge/death
Antibiotic allergy label removed: yes (1)/no (0)	Until 100 days after discharge
Antibiotic allergy label refined: yes (1)/no (0)	Until 100 days after discharge
Beta-lactam antibiotic tolerance: yes (1)/no (0)	Until 100 days after discharge
3 months post-hospitalization mortality: yes (1)/ no (0)	Until 14 days after discharge
Length of hospital stay (days)	Until 14 days after discharge	Calculated as (date of discharge) - (date of admission) + 1
Admission to ICU: yes (1)/no (0)	Until 14 days after discharge
Readmission within 3 months after discharge: yes (1)/no (0)	Until 100 days after discharge
Colonization with MRSA: yes (1)/no (0)	Until 100 days after discharge
Infection with MRSA: yes (1)/no (0)	Until 100 days after discharge
Colonization with VRE: yes (1)/no (0)	Until 100 days after discharge
Infection with VRE: yes (1)/no (0)	Until 100 days after discharge
Colonization with C.Diff: yes (1)/no (0)	Until 100 days after discharge
Infection with C.Diff: yes (1)/no (0)	Until 100 days after discharge
Cost of antibiotic treatment (euro)	Until 14 days after discharge
Cost of hospitalization (euro)	Until 14 days after discharge
Time needed to perform the AAL fact-check (minutes)	Until 14 days after discharge	AAL fact-check procedure will be timed by the investigator
Cost of human resources needed for AAL-fact-check (euro)	Until 14 days after discharge