跳至主要内容
临床试验/NCT03607734
NCT03607734已完成不适用

Penicillin Allergy De-Labelling in Elective Surgical Patients - A Study to Determine the Safety, Efficacy and Feasibility of Abbreviated Allergy Testing

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年4月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Completion of the study questionnaire by participants

研究概览

简要总结

Penicillin antibiotics are safe and inexpensive, and target selected bacteria rather than killing a broad range. Unfortunately, around 10% of the population are labelled as 'penicillin allergic'. This is often based on side effects such as rash and diarrhoea, and 90-95% of people with the label are not actually allergic to the drug.

The label leads to the use of alternative antibiotics, which tend to more toxic, and less specific about which bacteria they kill; this increases the risk of infections with so-called 'super-bugs', compared to patients without the label. People with the label also have an increased length of hospital stay and rates of readmission. These are significant problems for individuals, as well as wider society. Where the diagnosis is in doubt, the gold standard test for allergy is an oral challenge. Patients undergo skin +/- blood tests prior to a challenge, as these can help make the diagnosis. This combined pathway is expensive and time consuming, so testing cannot be offered routinely to all patients. However in patients with 'historic' reactions (many years previously), skin and blood tests become much less useful; in one study, 100% of patients who skin tested positive for amoxycillin allergy, tested negative 5 years later. Patients with historic reactions can therefore proceed directly to an oral challenge without prior skin or blood testing, since these offer little help in making the diagnosis. This streamlines the pathway, making it quick, non-invasive and cheap. Already established practice in several centres in Europe and beyond, this abbreviated pathway is offered on an ad-hoc basis in some centres in the UK.

The aim is to demonstrate that this pathway offers a safe and effective way to perform large-scale delabelling of elective surgical patients, who might not otherwise meet NICE criteria for testing.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Allergic history is historic (more than 10 years ago) and suggestive of a non-immediate reaction or side effect
  • Requires penicillin as first-line treatment for their planned surgery
  • >18 years
  • Willing and able to give consent

排除标准

  • Not willing to participate
  • History suggestive of immediate type reaction (anaphylaxis)
  • History of toxic epidermal necrolysis or Stevens Johnson syndrome
  • Pregnant, planning to become pregnant during study, or breastfeeding

研究组 & 干预措施

Group 1 - Interventional Treatment

Other

A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows:

  • 50mg amoxicillin (10% total dose)
  • 250mg amoxicillin (50% total dose)
  • 200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available.

干预措施: Amoxicillin (Drug)

结局指标

主要结局

Completion of the study questionnaire by participants

时间窗: 1 day

Online questionnaire about previously diagnosed allergies to be completed by study participants

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验