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B-lactam Databank Algorithm

Computational Decision Support For Penicillin Allergy Risk Stratification

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06243380
Enrollment
921
Registered
2024-02-06
Start date
2023-12-11
Completion date
2024-07-01
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Lactam Adverse Reaction

Brief summary

Background: Antibiotic allergy constitutes a major health problem with serious medical and financial consequences when under- but also overdiagnosed. About one and a half million Belgians report having an allergy to penicillin. However, in 1.35 million (90%) of these penicillin allergies, the suspicion is wrong. The issue of false penicillin allergy is therefore seen as an important medical problem with significant implications for the individual patient but also for society. Today, therefore, there is a global consensus to contain the pandemic of false penicillin allergy as much as possible. This should ultimately lead to correct antibiotic policies for the patient and reduce antibiotic resistance and the cost to society. The problem with this is that there is no diagnostic test that one can perform on a population of one and a half million people. This is practically and financially unfeasible. So there is a need for proper risk stratification based on anamnestic data to better guide our diagnostics. Specific question: The investigators currently have a database of about 1000 patients with a possible hypersensitivity to antibiotics who have been fully diagnosed according to current guidelines. The aim of the study is to use this database to see whether a tool can be developed to reliably perform an initial screening to determine in whom further testing is necessary and in whom, based purely on the story, it can be decided that the likelihood of penicillin allergy is extremely low and additional diagnostics are unnecessary.

Interventions

None listed

Sponsors

Universiteit Antwerpen
CollaboratorOTHER
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Adults and minors with a suspected allergy to beta-lactam antibiotics

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy6 monthsA screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026