About this trial
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 world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Single dose low-risk penicillin challenge
Diagnostic testInitial screening to establish low risk allergy status followed by a single dose challenge using a standard penicillin dose. All challenges will be oral, conducted in a hospital setting and will be followed by a 1 hour monitoring period.
Treatment groups
Trial outcomes
Primary outcomes
How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting?
Successful operation of the high-volume clinic model, assessed via: 1. Number of patients reviewed and tested (if appropriate) within each allocated session 2. Evidence of acceptability to patients from feedback forms
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: