HATRIC - Feasibility study of Pelargonium sidoides root extract, EPs®7630 (Kaloba®), for the treatment of acute cough due to lower respiratory tract infection in adults: a double blind, placebo controlled randomised trial.

Conference:

SAPC ASM 2019 - Exeter

Talk Code:

4D.5

Presenter:

Michael Moore

Co-authors:

Catherine Simpson, Merlin Willcox, Gareth Griffiths, Paul Little, Alastair Hay, Chris Butler, Lily Yao, Frances Webley, Amy Whitehead, Jennifer Bostock, Margaret Bell

Author institutions:

University of Southampton, University of Oxford, University of Bristol

Problem

Antibiotic resistance is rising and linked to prescribing in primary care. Acute lower tract infection (LRTI) is a common acute infection managed in primary care. The majority of patients are prescribed antibiotics, despite the lack of evidence of benefit. A delayed prescription strategy has been successful in reducing antibiotic prescribing rates for LRTIs but identifying a safe and effective method of symptom control would likely reduce antibiotic use further. A Cochrane review suggests that Pelargonium sidoides root extract has some benefit.

Approach

HATRIC is a mixed methods double blind, placebo controlled, cluster randomised feasibility study with four arms comparing Pelargonium sidoides root extract EPs ®7630 liquid vs. liquid placebo and Pelargonium sidoides root extract EPs ®7630 tablet vs. tablet placebo. GP practices were cluster-randomised to give tablet or liquid formulation and within each practice, eligible patients were randomised to active or placebo IMP. Adults aged 18 years and over presenting with an acute cough (≤21 days' duration) as their main symptom and with symptoms localising to the lower tract, for which an infective diagnosis was judged very likely were recruited in primary care. In addition to the intervention, clinicians were able to offer one of three antibiotic strategies; immediate antibiotics, delayed antibiotics or no antibiotics. A notes review was undertaken at 28 days to document reconsultations with a LRTI. The aim of the HATRIC feasibility study is to demonstrate the ability to recruit and retain participants and conduct a placebo controlled trial of Pelargonium sidoides extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected.

Findings

Recruitment took place between March and December 2018 from 20 practices in England (Wessex Region). 134 patients were recruited and diaries containing all key information were obtained from 107 (80%) participants. More detail on demographics and outcome measures will be presented at the conference.

Consequences

If this feasibility study leads to a successful full RCT that shows Pelargonium sidoides root extract is effective in reducing the symptom burden of LRTI then antibiotic prescribing for LRTI may decrease. Thus minimising the long-term public health risks of inappropriate antibiotics and providing a model for different management strategies for other Respiratory Tract Infections (RTIs).

Submitted by:

Catherine Simpson

Funding acknowledgement:

The clinical trial was coordinated by the Southampton Clinical Trials Unit, a UKCRC registered, NIHR support funded Clinical Trials Unit. The trial was sponsored by the University of Southampton and funded by the NIHR School of Primary Care.