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.
Acute lower respiratory infection is common and despite the lack of evidence of benefit antibiotics are often prescribed. Identifying a safe and effective method of symptom control would likely further reduce antibiotic uptake. A Cochrane review suggests that Pelargonium sidoides root extract (Kaloba®) has some benefit. HATRIC is a Phase II feasibility study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of lower respiratory tract infection in adults.
The objective is to determine the feasibility of conducting a fully powered trial of Pelargonium sidoides root extract as an alternative to antibiotics for lower respiratory tract infections in UK primary care.
Hatric is a mixed methods double blind, placebo controlled, cluster randomised feasibility study with four arms. Practices will be randomised to tablet or liquid formulation. Patients will be randomised to active or placebo.
160 patients will be randomised to one of four groups:
1) Liquid Pelargonium sidoides root extract EPs®7630 - 30 drops 3x daily
2) Liquid placebo - 30 drops 3x daily
3) Tablet Pelargonium sidoides root extract EPs®7630 – one 20mg tablet 3x daily
4) Tablet placebo - one 20mg tablet 3x daily
Patients will take the trial medication daily until 2 – 3 days after symptoms have resolved but treatment duration should not exceed 2 weeks. The use of the delayed prescription strategy for antibiotics will be encouraged but clinicians will be able to offer one of three following antibiotic strategies in addition to the randomised intervention:
1) Immediate antibiotics
2) Delayed antibiotics
3) No antibiotics
Patients will complete a symptom diary for up to four weeks. A notes review will be undertaken at one month.
Completed
Adults 18 years and over presenting to their GP with an acute cough (≤21 days' duration) as their main symptom and with symptoms localising to the lower tract (e.g. sputum, chest pain, dyspnoea wheeze), for which an infective diagnoses is judged very likely.
All Trial enquiries should be addressed to ctu@soton.ac.uk