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

NCT06532448 | Not Yet Recruiting

• 1 other identifier: RHM MED2073
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Penicillin Allergy

Outcome Measures

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

  1 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Central Study Contacts

Mandy Ross

CONTACT

02381205213; mandy.ross@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share