Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting

Launched by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help patients who have been labeled as allergic to penicillin. Many patients avoid penicillin due to this label, even though their allergy might not be serious. The study aims to find out how we can safely and efficiently help more people remove this label in a clinic setting. By doing this, we hope to improve how antibiotics are used, especially since so many patients are affected and there aren't enough allergy clinics available.

To participate, you need to be at least 18 years old, have a penicillin allergy label, and be a registered patient at the University Hospital Southampton NHS Foundation Trust. However, some people cannot join, such as those with a history of severe allergic reactions to penicillin or other serious medical conditions. If eligible, participants can expect to go through a safe process to reassess their allergy and possibly have their penicillin allergy label removed, which could open up more treatment options for them in the future.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Penicillin allergy label
• • 2. Age ≥18
• • 3. Registered as a patient with University Hospital Southampton NHS Foundation Trust (with a UHS medical record)
• • 4. Able and willing to consent to penicillin de-labelling
• Exclusion Criteria:
• • 1. Penicillin allergy previously confirmed via positive blood, skin, BAT or challenge testing
• • 2. PEN-FAST score \>2 (indicating a moderate or high risk of a positive challenge)
• • 3. Anaphylaxis, angioedema, wheeze, shortness of breath or suspected hypotension linked to treatment with penicillin
• • 4. Received treatment in hospital for a reaction linked to penicillin (unless already an inpatient at onset)
• • 5. Itchy or urticarial rash within 1 hour of starting a new course of treatment with penicillin
• • 6. Severe cutaneous adverse reaction (SCAR) linked to penicillin exposure (e.g. SJS/TEN, DRESS), including symptoms suggestive of SCAR without a formal diagnosis (e.g. skin blistering or peeling, mucosal involvement)
• • 7. History of other serious, non-immediate reactions linked to penicillin (e.g. haemolytic anaemia, transaminitis, nephritis)
• • 8. Currently pregnant or breastfeeding
• • 9. Poorly controlled asthma
• • 10. Severe COPD
• • 11. Severe or critical aortic stenosis
• • 12. Clinically unstable secondary to other organ failure
• • 13. Unwell or unstable on the day of proposed penicillin challenge (including acute febrile illness)
• • 14. Prescribed other antibiotics on the day of proposed challenge, unless taken as a long-term treatment/prophylaxis