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NCT06243380
B-lactam Databank Algorithm
trial in Beta Lactam Adverse Reaction in 921 participants. Completed in 1 July 2024.
1 July 2024
Quick facts
| Lead sponsor | University Hospital, Antwerp |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 921 |
| Start date | 11 December 2023 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 July 2024 |
| Sites | 1 location across Belgium |
Conditions studied
- Beta Lactam Adverse Reaction — all drugs for Beta Lactam Adverse Reaction →
Sponsor
University Hospital, Antwerp
Who can join
Eligibility, any sex, with Beta Lactam Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06243380
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other recruiting trials for Beta Lactam Adverse Reaction
Currently open trials in the same condition.
- NCT06406114 — Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing · Phase 2 · recruiting
Other University Hospital, Antwerp trials
Trials by the same sponsor.
- NCT07455422 — A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurr · NA · not yet recruiting
- NCT07020715 — A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis · Phase 2 · not yet recruiting
- NCT07443761 — Patients Undergoing Pancreatic Surgery at the Antwerp University Hospital. · active not recruiting
- NCT06372847 — DISE-HNS Effect Study · NA · recruiting
- NCT07189091 — CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06243380 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Antwerp
- Last refreshed: 19 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06243380.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing