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HATRIC: a study of Pelargonium sidoides 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

HATRIC: a study of Pelargonium sidoides 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
HATRIC: a study of Pelargonium sidoides 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
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 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.

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 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.

Discussion: 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.

Trial registration: HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018.
Feasibility, Herbal, Double-blind randomised, retention, variance, stratification, Lower respiratory tract, acute bronchitis, cluster randomised
2055-5784
Whitehead, Amy
7bd4e1d1-078b-4f2b-bfc9-ed44ba0a195a
Simpson, Catherine
60c008cf-9ba0-4c41-815c-ad66a04aaed2
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Webley, Frances
143f965b-866b-4455-89a5-d187f52e1cde
Hay, Alastair
daf3c71f-5e5a-4bee-9bb8-7df67ec2a79f
Butler, Chris
95583b3d-b015-42de-ba2d-10de4ba67707
Yao, Lily
7b003c8c-4478-479e-9071-418ea4c503fb
Wrixon, Emma
bc05ea9a-42c2-48ab-a1a9-3086367fb452
Bell, Margaret
836c2c8e-4f09-41a8-878a-f7f7620ca119
Bostock, Jennifer
bdb3d9f2-9e5a-4d33-bb38-94bf6298db75
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Whitehead, Amy
7bd4e1d1-078b-4f2b-bfc9-ed44ba0a195a
Simpson, Catherine
60c008cf-9ba0-4c41-815c-ad66a04aaed2
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Webley, Frances
143f965b-866b-4455-89a5-d187f52e1cde
Hay, Alastair
daf3c71f-5e5a-4bee-9bb8-7df67ec2a79f
Butler, Chris
95583b3d-b015-42de-ba2d-10de4ba67707
Yao, Lily
7b003c8c-4478-479e-9071-418ea4c503fb
Wrixon, Emma
bc05ea9a-42c2-48ab-a1a9-3086367fb452
Bell, Margaret
836c2c8e-4f09-41a8-878a-f7f7620ca119
Bostock, Jennifer
bdb3d9f2-9e5a-4d33-bb38-94bf6298db75
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99

Whitehead, Amy, Simpson, Catherine, Willcox, Merlin, Webley, Frances, Hay, Alastair, Butler, Chris, Yao, Lily, Wrixon, Emma, Bell, Margaret, Bostock, Jennifer, Little, Paul, Griffiths, Gareth and Moore, Michael (2019) HATRIC: a study of Pelargonium sidoides 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. Pilot and Feasibility Studies, 5 (1), [98]. (doi:10.1186/s40814-019-0478-6).

Record type: Article

Abstract

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 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.

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 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.

Discussion: 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.

Trial registration: HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018.

This record has no associated files available for download.

More information

e-pub ahead of print date: 31 July 2019
Keywords: Feasibility, Herbal, Double-blind randomised, retention, variance, stratification, Lower respiratory tract, acute bronchitis, cluster randomised

Identifiers

Local EPrints ID: 433891
URI: http://eprints.soton.ac.uk/id/eprint/433891
ISSN: 2055-5784
PURE UUID: 17150884-e212-48d6-92d1-32d1639ed8cb
ORCID for Merlin Willcox: ORCID iD orcid.org/0000-0002-5227-3444
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

Catalogue record

Date deposited: 05 Sep 2019 16:30
Last modified: 11 Jul 2024 01:57

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Contributors

Author: Amy Whitehead
Author: Catherine Simpson
Author: Merlin Willcox ORCID iD
Author: Frances Webley
Author: Alastair Hay
Author: Chris Butler
Author: Lily Yao
Author: Emma Wrixon
Author: Margaret Bell
Author: Jennifer Bostock
Author: Paul Little ORCID iD
Author: Michael Moore ORCID iD

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