Penicillin Allergy De-labelling Study (SPACE study)
Research type
Research Study
Full title
A Multicentre Study to Investigate a Protocol-Driven Multidisciplinary Service Model to Tackle ‘Spurious Penicillin Allergy’ in Secondary Care (SPACE study)
IRAS ID
293544
Contact name
Mamidipudi Thirumala Krishna
Contact email
Sponsor organisation
R&D Department
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Around 6% of people carry a penicillin allergy label and 90-95% of these labels are inaccurate. Patients with penicillin allergy labels receive alternative antibiotics which increase the risk of serious infections, lengthens hospital stay and increases NHS costs. Penicillin allergy testing is onerous and needs a specialist. This is not routinely available in all hospitals.
We have developed a simple method to remove inaccurate labels based on a careful review of the clinical history without the need for allergy tests. This involves giving penicillin orally under supervision (challenge procedure) to those who are unlikely to be allergic (‘low-risk’) on clinical assessment.
We will find out what patients, healthcare workers and managers think about the challenge procedure to remove incorrect labels in ‘low-risk’ patients. We will design a safe way to start using the challenge procedure in hospitals and estimate costs.
The study includes patients ≥18years with a penicillin allergy label, who are clinically stable and can give informed consent. This study will be carried out in 3 hospitals over 24 months and will include 375 patients from different areas including medical, surgical and cancer care. The research team will review patients with a penicillin allergy label and triage them into ‘low risk’ and ‘high-risk’ groups. ‘Low-risk’ patients will be offered the challenge procedure. ‘High risk’ patients and those declining the challenge procedure will receive standard care in line with NICE guidelines. We will interview patients in ‘low risk’ group to find out how many are willing to undergo the challenge procedure and describe how they get on. We will also interview groups of healthcare workers and managers to better understand their perspectives. Finally, we will look at how we might offer the challenge procedure at scale within hospitals and what this might cost.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/PR/0814
Date of REC Opinion
23 Jul 2021
REC opinion
Further Information Favourable Opinion