Antibiotic Allergy
Conditions
Keywords
Penicillin allergy, Delabeling, beta-lactam, electronic health records, clinical decision support, Antibiotic allergy, drug allergy
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).
Interventions
OTHEREPR 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
Sponsors
Noorderhart Pelt
AZ Herentals
Heilig Hartziekenhuis, Mol
AZ Turnhout
Sint-Jozefskliniek Izegem
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Multi-centre open label cross-over cluster-randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Antibiotic allergy label removed: 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 | — |
| Colonization with MRSA: yes (1)/no (0) | Until 100 days after discharge | — |
Countries
Belgium
Contacts
Primary ContactLiesbeth Gilissen, PhD
Outcome results
None listed