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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06243380
Other study ID # 003364
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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