Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Patient Representative, United Kingdom.
PLoS One. 2024 May 20;19(5):e0302302. doi: 10.1371/journal.pone.0302302. eCollection 2024.
Antibiotics are prescribed for over 50% of respiratory tract infections in primary care, despite good evidence of there being no benefit to the patient, and evidence of over prescribing driving microbial resistance. The high treatment rates are attributed to uncertainty regarding microbiological cause and clinical prognosis. Point-of-care-tests have been proposed as potential antibiotic stewardship tools, with some providing microbiological results in 15 minutes. However, there is little research on their impact on antibiotic use and clinical outcomes in primary care.
This is a multi-centre, individually randomised controlled trial with mixed-methods investigation of microbial, behavioural and antibiotic mechanisms on outcomes in patients aged 12 months and over presenting to primary care in the UK with a suspected respiratory tract infection, where the clinician and/or patient thinks antibiotic treatment may be, or is, necessary. Once consented, all participants are asked to provide a combined nose and throat swab sample and randomised to have a rapid microbiological point-of-care-test or no point-of-care-test. For intervention patients, clinicians review the result of the test, before contacting the patient to finalise treatment. Treatment decisions are made as per usual care in control group patients. The primary outcome is whether an antibiotic is prescribed at this point. All swab samples are sent to the central laboratory for further testing. Patients are asked to complete a diary to record the severity and duration of symptoms until resolution or day 28, and questionnaires at 2 months about their beliefs and intention to consult for similar future illnesses. Primary care medical records are also reviewed at 6-months to collect further infection consultations, antibiotic prescribing and hospital admissions. The trial aims to recruit 514 patients to achieve 90% power with 5% significance to detect a 15% absolute reduction in antibiotic prescribing. Qualitative interviews are being conducted with approximately 20 clinicians and 30 participants to understand any changes in beliefs and behaviour resulting from the point-of-care-test and generate attributes for clinician and patient discrete choice experiments.
This trial will provide evidence of efficacy, acceptability and mechanisms of action of a rapid microbiological point-of-care test on antibiotic prescribing and patient symptoms in primary care.
ISRCTN16039192, prospectively registered on 08/11/2022.
尽管有充分的证据表明抗生素对患者没有益处，并且过度处方会导致微生物耐药性的增加，但在初级保健中，仍有超过 50%的呼吸道感染患者接受了抗生素治疗。高治疗率归因于对微生物病因和临床预后的不确定性。即时检测已被提议作为潜在的抗生素管理工具，其中一些可在 15 分钟内提供微生物学结果。然而，关于其在初级保健中对抗生素使用和临床结局的影响的研究甚少。
这是一项多中心、个体随机对照试验，采用混合方法研究了微生物学、行为学和抗生素机制对英国初级保健中 12 个月及以上因疑似呼吸道感染就诊的患者的结局的影响，在这些患者中，临床医生和/或患者认为可能需要或正在使用抗生素治疗。一旦获得同意，所有参与者都被要求提供一个鼻腔和咽喉联合拭子样本，并随机分为接受快速微生物即时检测或不接受即时检测。对于干预组患者，临床医生会在联系患者以确定最终治疗方案之前查看检测结果。对照组患者的治疗决策则按照常规进行。主要结局是在此刻是否开具抗生素。所有拭子样本均被送往中央实验室进行进一步检测。患者被要求填写一份日记，记录症状的严重程度和持续时间，直到症状缓解或第 28 天，并在 2 个月时填写关于他们对类似未来疾病就诊的信念和意向的问卷。在 6 个月时还会对初级保健医疗记录进行回顾，以收集进一步的感染咨询、抗生素处方和住院情况。该试验旨在招募 514 名患者，以 90%的功效和 5%的显著性检测出抗生素处方绝对减少 15%的效果。还对大约 20 名临床医生和 30 名患者进行了定性访谈，以了解即时检测对信念和行为的任何改变，并为临床医生和患者的离散选择实验生成属性。
本试验将提供关于快速微生物即时检测对初级保健中抗生素处方和患者症状的疗效、可接受性和作用机制的证据。
ISRCTN84102441，于 2022 年 11 月 8 日前瞻性注册。
