NCT06532448

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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, low-risk candidates will be identified. Appointments will be offered to fill 36 clinic slots in total as part of the study. On the day of their appointment, after providing written consent, participants will be asked some additional questions to confirm their eligibility for penicillin allergy de-labelling (and that the information provided in their referral form is accurate). Simple medical observations will also be taken (recording heart rate, blood pressure and oxygen saturation). Participants may be asked to return to the waiting area after these initial assessments. Once a chair becomes available in the clinic, participants will be given a single dose of penicillin to take by mouth. They will then be observed for 1 hour. During this time they will be asked to complete a feedback form about their clinic experience. Provided they do not experience a reaction they will then be discharged home, where they will be asked to complete a 3-day course of the same penicillin. They will be called during the next week to ensure that they completed the course and did not experience any delayed reactions. Their GP, and the person who referred to the service, will be informed of the outcome. Those that do not react will be able to receive penicillins in the future. Participants should expect to be in the allergy department for up to 2 hours for their appointment. The study does not need to be powered to make a specific statistical analysis possible; the intention is simply to demonstrate that a high-volume de-labelling service is viable. However, any one session may be affected by factors such as a high DNA rate, which would then mean that the clinic model is not tested at optimal capacity. To avoid this, and to make the overall results more compelling, the clinic will run on four occasions (with 36 patients in total).

Conditions

• Penicillin Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Single dose low-risk penicillin challenge	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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-08-01
• Last updated: 2024-08-05