Status:
NOT_YET_RECRUITING
Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Conditions:
Penicillin Allergy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real wo...
Detailed Description
Participants with a penicillin allergy label will be invited to take part in the study, having been referred to the service by their hospital team. Based on the information provided with the referral,...
Eligibility Criteria
Inclusion
- Penicillin allergy label
- Age ≥18
- Registered as a patient with University Hospital Southampton NHS Foundation Trust (with a UHS medical record)
- Able and willing to consent to penicillin de-labelling
Exclusion
- Penicillin allergy previously confirmed via positive blood, skin, BAT or challenge testing
- PEN-FAST score \>2 (indicating a moderate or high risk of a positive challenge)
- Anaphylaxis, angioedema, wheeze, shortness of breath or suspected hypotension linked to treatment with penicillin
- Received treatment in hospital for a reaction linked to penicillin (unless already an inpatient at onset)
- Itchy or urticarial rash within 1 hour of starting a new course of treatment with penicillin
- 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)
- History of other serious, non-immediate reactions linked to penicillin (e.g. haemolytic anaemia, transaminitis, nephritis)
- Currently pregnant or breastfeeding
- Poorly controlled asthma
- Severe COPD
- Severe or critical aortic stenosis
- Clinically unstable secondary to other organ failure
- Unwell or unstable on the day of proposed penicillin challenge (including acute febrile illness)
- Prescribed other antibiotics on the day of proposed challenge, unless taken as a long-term treatment/prophylaxis
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06532448
Start Date
October 1 2024
End Date
October 1 2025
Last Update
August 5 2024
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