B-lactam Databank Algorithm

Beta Lactam Adverse Reaction Clinical Trial

Official title:

Computational Decision Support For Penicillin Allergy Risk Stratification

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06243380
• Other study ID #: 003364
• Status: Active, not recruiting
• Start date: December 11, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 921
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Beta Lactam Adverse Reaction

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy	A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy	6 months