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| Name | Class |
|---|---|
| Noorderhart Pelt | OTHER |
| AZ Herentals | UNKNOWN |
| Heilig Hartziekenhuis, Mol | UNKNOWN |
| AZ Turnhout |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAL fact-check | Experimental | Semi-automated EPR search for re-exposure |
|
| Standard of care (no AAL fact-check) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPR search | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| First 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. | Until 100 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liesbeth Gilissen, PhD | Contact | +32 16 71 00 84 | liesbeth.gilissen@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Rik Schrijvers, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | Belgium |
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| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| OTHER |
| Sint-Jozefskliniek Izegem | OTHER |
Multi-centre open label cross-over cluster-randomized controlled trial
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|
| 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) | Calculated as (date of discharge) - (date of admission) + 1 | Until 14 days after discharge |
| 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) | AAL fact-check procedure will be timed by the investigator | Until 14 days after discharge |
| Cost of human resources needed for AAL-fact-check (euro) | Until 14 days after discharge |