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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.
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.
Afiliación
  • Whitehead A; 1Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD UK.
  • Simpson C; 1Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD UK.
  • Willcox M; 2Primary Care and Population Science, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST UK.
  • Webley F; 1Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD UK.
  • Hay AD; 3Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, BS8 2PS UK.
  • Butler C; 4Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, OX2 6GG UK.
  • Yao L; 5Department of Health Sciences, University of Leicester, Leicester, LE1 7RH UK.
  • Wrixon E; 1Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD UK.
  • Bell M; 2Primary Care and Population Science, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST UK.
  • Bostock J; 2Primary Care and Population Science, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST UK.
  • Little P; 2Primary Care and Population Science, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST UK.
  • Griffiths G; 1Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton MP131, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD UK.
  • Moore M; 2Primary Care and Population Science, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST UK.
Article en En | MEDLINE | ID: mdl-31384480
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Guideline Idioma: En Revista: Pilot Feasibility Stud Año: 2019 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Guideline Idioma: En Revista: Pilot Feasibility Stud Año: 2019 Tipo del documento: Article Pais de publicación: Reino Unido