The Drug Allergy Registry Study
Research type
Research Study
Full title
The Drug Allergy Registry Study: investigating the risk factors, epidemiology, underlying mechanisms, outcomes and ideal diagnostic pathways in drug allergy
IRAS ID
326957
Contact name
louise savic
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Drug allergy is a significant public health burden and an under-researched disease area. The common cause of fatal allergic reactions is to drugs, and this is a particular problem for patients undergoing surgery and anaesthesia where where 1:5000 suffer a life-threatening allergic reaction. Excessive caution around potential drug allergy has led to around 1 in 4 patients carrying a label of drug allergy, the vast majority of which are incorrect. These labels impact negatively on healthcare; for example, being labelled as 'penicillin allergic' is associated with worse patient outcomes and sub-optimal antimicrobial management, but is incorrect in 95% of people. The parallel problems of false allergy labels and severe, unpredictable allergic reactions, are interdependent, and an accurate allergy diagnosis is key to solving both problems.
We have a very limited repertoire of tools with which to diagnose drug allergy. Skin testing is the main diagnostic tool but can be unreliable. Typically, a confident diagnosis can only be made by re-administering the drug and observing the patient for signs of allergy (provocation testing). This exposes patients to potentially significant risk, especially in the context of anaesthetic drugs. In addition, we have limited understanding of the mechanisms underlying drug allergy, what the risk factors are for developing allergy, whether allergy can be prevented, or what the longterm effects of drug allergy labels are.
In this study we aim to identify the epidemiology, causes, underlying mechanisms, risk factors and longterm outcomes of drug allergy. We will develop novel in-vitro diagnostic tests and work with external collaborators to validate these. This will reduce the need for drug provocation testing for future patients and help us develop safe and effective diagnostic pathways. We will also collect longterm outcome data, as well as DNA for future studies into possible genetic risk factors for drug allergy.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/PR/0799
Date of REC Opinion
14 Aug 2023
REC opinion
Further Information Favourable Opinion