HATRIC：一项关于根提取物EPs®7630（Kaloba®）治疗成人下呼吸道感染所致急性咳嗽的双盲、安慰剂对照随机可行性试验的研究方案。
HATRIC: a study of root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults-study protocol for a double blind, placebo-controlled randomised feasibility trial.
作者信息
Whitehead Amy, Simpson Catherine, Willcox Merlin, Webley Frances, Hay Alastair D, Butler Chris, Yao Lily, Wrixon Emma, Bell Margaret, Bostock Jennifer, Little Paul, Griffiths Gareth, Moore Michael
机构信息
1Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD UK.
2Primary Care and Population Science, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST UK.
出版信息
Pilot Feasibility Stud. 2019 Jul 31;5:98. doi: 10.1186/s40814-019-0478-6. eCollection 2019.
BACKGROUND
Acute lower respiratory tract infection is a common acute infection managed in primary care. The current dominant management strategy in the UK is antibiotics, despite widespread publicity regarding antimicrobial resistance and evidence that the small benefits of antibiotics do not outweigh the harms. There is a need to address the rising problem of antibiotic resistance by providing credible alternative strategies, which reduce symptom burden. There is sufficient evidence to recommend the use of root extract in order to warrant undertaking an independent clinical trial.We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebo-controlled trial of extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included.
METHODS
The HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of root extract as an alternative to the inappropriate use of antibiotics for acute bronchitis in UK primary care.Primary care sites will be equally randomised to one of two formulation groups (tablet or liquid preparation). Additionally, within each site, patients will be evenly randomised to active or placebo treatment. Antibiotic consumption will be monitored during the trial, but the use of a delayed prescription strategy is encouraged. The target sample size for this study is 160 patients overall or 40 per arm, recruited from approximately 20 primary care sites. The analysis will be descriptive focusing on estimation with no formal comparison of groups taking place.
DISCUSSION
If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of root extract for the treatment of lower respiratory tract infections in primary care.
TRIAL REGISTRATION
HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018.
背景
急性下呼吸道感染是基层医疗中常见的急性感染。在英国，目前主要的治疗策略是使用抗生素，尽管广泛宣传了抗菌药物耐药性问题，且有证据表明抗生素的微小益处并不大于危害。有必要通过提供可靠的替代策略来解决日益严重的抗生素耐药性问题，这些策略可减轻症状负担。有充分证据推荐使用根提取物，因此有必要开展一项独立的临床试验。我们提议进行一项可行性研究，以证明我们招募和留住患者的能力，并在不怀疑有肺炎的下呼吸道感染中进行提取物EPs®7630的安慰剂对照试验。片剂和液体制剂都将纳入。
方法
HATRIC试验是一项双盲随机安慰剂对照可行性研究，旨在确定在英国基层医疗中开展一项充分有力的试验，以根提取物替代不适当使用抗生素治疗急性支气管炎的潜力。基层医疗点将被随机分为两个制剂组（片剂或液体制剂）之一。此外，在每个医疗点内，患者将被随机分为活性治疗组或安慰剂治疗组。试验期间将监测抗生素的使用情况，但鼓励采用延迟处方策略。本研究的目标样本量为总共160名患者，每组40名，从大约20个基层医疗点招募。分析将是描述性的，重点在于估计，不进行组间的正式比较。
讨论
如果该试验证明了招募和实施的可行性，我们将寻求资金开展一项充分有力的安慰剂对照试验，以根提取物治疗基层医疗中的下呼吸道感染。
试验注册
HATRIC于2018年8月16日在ISRCTN注册库（ISRCTN17672884）注册。
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