Beta Lactam Adverse ReactionNCT06243380
B-lactam Databank Algorithm
An observational study of Beta Lactam Adverse Reaction, run by University Hospital, Antwerp at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Beta Lactam Adverse Reaction
- How many people
- 921 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and minors with a suspected allergy to beta-lactam antibiotics.
Who may be able to join
- Adults and minors with a suspected allergy to beta-lactam antibiotics
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computational Decision Support For Penicillin Allergy Risk Stratification
Background:
Antibiotic allergy constitutes a major health problem with serious medical and financial consequences when under- but also overdiagnosed.
Read more
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.
- Conditions
- Beta Lactam Adverse Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a possible allergy to beta-lactam antibiotics | Minors and adults with a possible allergy to beta-lactam antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start11 Dec 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Lactam Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243380
- Sponsor's protocol ID
- 003364
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Decision Support For Penicillin Allergy Risk Stratification
- ClinicalTrials.gov ID
- NCT06243380
- Acronym / sponsor ID
- 003364
- Conditions
- Beta Lactam Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a possible allergy to beta-lactam antibiotics | – | –Minors and adults with a possible allergy to beta-lactam antibiotics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and minors with a suspected allergy to beta-lactam antibiotics.
Key inclusion criteria (1 listed)
- Adults and minors with a suspected allergy to beta-lactam antibiotics
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy
Time frame: 6 months
A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Beta Lactam Adverse Reaction
RecruitingPhase 2
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Drug Allergy, Cephalosporin Allergy
RecruitingObservational study
Optimization of Perioperative Antibiotic Prophylaxis in Patients Allergic to Beta-lactams in the Orthopedic Surgery and Trauma Departments
Beta Lactam Adverse Reaction
Recruiting
Support Tool for Antibiotic Allergy deLabeling
Antibiotic Allergy
Not yet recruiting
In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping
Drug Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta Lactam Adverse Reaction, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A screening tool for the likelihood of penicillin allergy in patients with a selfreported penicillin allergy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.