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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
3,000
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
University Hospitals Leuven
Leuven, Belgium
RECRUITINGFirst 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.
Time frame: Until 100 days after discharge
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)
Calculated as (date of discharge) - (date of admission) + 1
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
Colonization with VRE: yes (1)/no (0)
Time frame: Until 100 days after discharge
Infection with VRE: yes (1)/no (0)
Time frame: Until 100 days after discharge
Colonization with C.Diff: yes (1)/no (0)
Time frame: Until 100 days after discharge
Infection with C.Diff: yes (1)/no (0)
Time frame: Until 100 days after discharge
Cost of antibiotic treatment (euro)
Time frame: Until 14 days after discharge
Cost of hospitalization (euro)
Time frame: Until 14 days after discharge
Time needed to perform the AAL fact-check (minutes)
AAL fact-check procedure will be timed by the investigator
Time frame: Until 14 days after discharge
Cost of human resources needed for AAL-fact-check (euro)
Time frame: Until 14 days after discharge
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