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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Southampton NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Single dose low-risk penicillin challenge

    Diagnostic test

    Initial 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: