Abstract
BackgroundAcute 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.MethodsThe 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.DiscussionIf 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.Trial registrationHATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018.
Highlights
Acute lower respiratory tract infection is a common acute infection managed in primary care
(2019) 5:98 (Continued from previous page). 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
Acute non-pneumonic lower respiratory tract infection (LRTI)/acute bronchitis is a common acute infection managed in primary care
Summary
Acute lower respiratory tract infection is a common acute infection managed in primary care. We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebocontrolled 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 impact of effective alternative treatments for respiratory infections is likely to be in minimising unnecessarily severe or prolonged symptoms and avoiding side effects from unnecessary antibiotics; minimising the long-term public health risks of inappropriate antibiotics and providing a model for different management strategies for other respiratory tract infections (RTIs)
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