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 Pelargonium sidoides 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 Pelargonium sidoides extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included. The HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of Pelargonium sidoides 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. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of Pelargonium sidoides root extract for the treatment of lower respiratory tract infections in primary care. HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018.

中文翻译：

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HATRIC：天竺葵根提取物 EPs®7630 (Kaloba®) 用于治疗成人下呼吸道感染引起的急性咳嗽的研究——双盲、安慰剂对照随机可行性试验的研究方案

急性下呼吸道感染是初级保健中常见的急性感染。英国目前的主要管理策略是抗生素，尽管关于抗菌素耐药性的广泛宣传和证据表明抗生素的微小益处并没有超过危害。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，从而减轻症状负担。有足够的证据推荐使用天竺葵根提取物，以保证进行独立的临床试验。我们提出了一项可行性研究，以证明我们有能力招募和留住患者，并对天竺葵提取物 EPs®7630 在不怀疑肺炎的下呼吸道感染中进行安慰剂对照试验。片剂和液体制剂都将包括在内。HATRIC 试验是一项双盲随机安慰剂对照可行性研究，旨在确定对天竺葵根提取物进行全面试验的潜力，以替代英国初级保健中不恰当地使用抗生素治疗急性支气管炎。初级保健站点将同样随机分配到两个制剂组（片剂或液体制剂）中的一个。此外，在每个站点内，患者将被均匀地随机分配到积极治疗或安慰剂治疗。试验期间将监测抗生素的使用情况，但鼓励使用延迟处方策略。本研究的目标样本量是总共 160 名患者或每组 40 名患者，从大约 20 个初级保健中心招募。分析将是描述性的，侧重于估计，没有对组进行正式比较。如果该试验证明了招募和交付的可行性，我们将寻求资金用于天竺葵根提取物的全功率安慰剂对照试验，用于治疗初级保健中的下呼吸道感染。HATRIC 于 2018 年 8 月 16 日在 ISRCTN 注册中心 (ISRCTN17672884) 注册。