NCT04108637已完成不适用
Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 823
- 试验地点
- 2
- 主要终点
- Penicillin prescribing
研究概览
简要总结
ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing
详细描述
- Antibiotics are important medicines for fighting infections caused by bacteria. Their widespread use has caused a worrying rise in antibiotic resistant bacteria, which are bacteria that are harder to control or kill with antibiotics. Patients with infections caused by antibiotic resistant bacteria are often ill for longer and have an increased risk of serious harm, including death. The spread of resistant bacteria can be slowed down by using antibiotics more carefully. Penicillins are an important group of antibiotics that are recommended treatment for many infections. Doctors will avoid prescribing penicillin for their patients who have a "penicillin allergy label" in their health records. These patients are usually prescribed different types of antibiotics for their infections. There is concern that these non-penicillin antibiotics may not work as well as penicillins, may cause more side-effects (including killing more of the body's "helpful" bacteria), and may be more expensive.
- About 9 out of 10 people who have a record of penicillin-allergy are found to be not truly allergic to penicillin when thoroughly tested. This means they could safely take penicillins. The aim of ALABAMA is to find out if people with a penicillin-allergy record in their GP health records really do have an allergy by carrying out specialist testing, and to see if it is possible to reduce the number of patients wrongly labelled as penicillin allergic. The investigators will find out if this results in better use of antibiotics and fewer days of symptoms, when patients are prescribed antibiotics for infection.
- The investigators are recruiting up to 140 GP practices in Yorkshire and Humber and the South West Peninsula to help with this research, and plans to include up to 1060 people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Participant is willing and able to give informed consent for participation in the study
- •Male or Female, aged 18 years or above
- •Current penicillin allergy (or sensitivity) record of any kind in their electronic health record
- •Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antibiotic or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months
- •N.B.1 Patients who have been formally tested for penicillin allergy in the past and been found not to be penicillin allergic but still have a medical record indicating a penicillin allergy, are eligible for the trial.
排除标准
- •Life expectancy estimated <1 year by GP
- •Unable to attend immunology clinic
- •Unsuitable for entry into testing pathway because:
- •Allergy history consistent with anaphylaxis to penicillin
- •History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin
- •Has been formally tested for penicillin allergy in the past and been found to be penicillin allergic
- •History of brittle/severe asthma or has had a course of steroids in the past 3 months for asthma or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions
- •Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle
- •Breastfeeding mothers
- •Taking beta blocker medication, and unable to temporarily withhold these on the day of penicillin allergy testing
- •Currently taking (or recently taken) systemic steroids and unable to stop these for 10 days pretesting.
- •Currently taking antihistamines and unable to temporarily withhold these for 72 hours pre-testing
- •GPs may also want to exclude vulnerable patients who are deemed to be unsuitable to participate for other reasons such as, but not limited to, terminal illness, reliability, mental illness, learning difficulties, anxiety, and other family circumstances.
- •N.B.1 Patients that are currently taking medicines with antihistamine properties that cannot be temporarily withheld, or patients with isolated dermographism, may still be eligible to participate but will need to be discussed with the research team prior to consent.
- •N.B.2 Pregnancy and breastfeeding exclusion criteria are only applicable at screening (due to potential risks of PAT); these patients would not need to be withdrawn if in follow up.
结局指标
主要结局
Penicillin prescribing
时间窗: Measured at up to 12 month post-randomisation
The proportion of participants who receive prescriptions for a penicillin when attending for predefined conditions where a penicillin is the first-line recommended antibiotic
次要结局
- Treatment "response failure"(Measured after first antibiotic prescription, which can occur any time during the follow-up period for patients(Up to 12 months post randomisation))
- Symptom duration(Measured up to 12 month post-randomisation)
- De-labelling(check performed at 3 and 12 months)
- Hospital admissions(Measured up to 12 month post-randomisation)
- Mortality rates(Measured up to 12 month post-randomisation)
- Length of hospital stays(Measured up to 12 month post-randomisation)
- Total antibiotic prescribing(Measured up to 12 month post-randomisation)
- To measure the influences on clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.(Within 12 months of practice recruitment of a proportion of tested patients)
- Meticillin-resistant Staphylococcus aureus (MRSA) infection/ colonisation(Measured up to 12 month post-randomisation)
- Clostridium difficile infection(Measured up to 12 month post-randomisation)
- Cost effectiveness for the PAAP intervention compared to usual care(Collated for period: randomisation to up to 12 months of randomisation)
- (Process evaluation) To explore patient and clinician experiences of trial procedures.(Within 12 months of practice recruitment of a proportion of tested patients)
- To measure changes in clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.(Within 12 months of practice recruitment of a proportion of tested patients)
研究者
Jonathan Sandoe
Associate Clinical Professor
University of Leeds
研究点 (2)
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