Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting?
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Penicillin allergy label
- •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
排除标准
- •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
结局指标
主要结局
How can low-risk penicillin allergy de-labelling be delivered with maximal efficiency in a resource limited setting?
时间窗: 1 year
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
次要结局
未报告次要终点