Table 2 Eligibility criteria for the HATRIC trial
Inclusion criteria | |
1. Adults 18 years and over | |
2. Presenting with an acute cough (≤ 21 days’ duration) as their main symptom | |
3. Presenting with symptoms localising to the lower tract (e.g. sputum, chest pain, dyspnoea, wheeze), for which an infective diagnosis is judged very likely | |
4. Willing and able to give written informed consent | |
Exclusion criteria | |
1. Suspected pneumonia (i.e. complicated lower respiratory tract infection) on the basis of focal chest signs (focal crepitations, bronchial breathing) and systemic features (severe breathlessness, high fever, vomiting, severe diarrhoea) | |
2. Signs of severity which may warrant hospital admission (e.g. SpO2 < 91% [30, 31], Systolic BP < 90 mmHg, Heart rate > 130) | |
3. Exacerbation of COPD | |
4. Serious chronic disorders where immediate antibiotics are needed (e.g. cystic fibrosis, valvular heart disease) | |
5. Unable to give informed consent or complete trial paperwork (including the patient diary) | |
6. Difficulty reading and understanding English and therefore unable to give informed consent or complete the trial paperwork (including the patient diary) | |
7. Known or suspected pregnancy | |
8. Women at risk of pregnancy (i.e. not on effective contraception—combined oral contraceptive pill, an intrauterine hormonal device, subcutaneous hormonal implant, or hormonal contraceptive injections) | |
9. Currently breast-feeding | |
10. Known immunodeficiency state or chemotherapy | |
11. Currently taking oral steroids | |
12. Using a Pelargonium sidoides/Kaloba® preparation and unwilling or unable to discontinue for the study period | |
13. Hypersensitivity to Pelargonium sidoides preparations or to the Kaloba brand | |
14. Increased tendency to bleeding or is taking coagulation-inhibiting drugs (e.g. warfarin) | |
15. Severe hepatic and renal diseases (Chronic Kidney Disease Stage 4, GFR < 30), as no adequate data are available in these areas | |
16. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption (tablet formulation only) | |
17. Previously entered the HATRIC trial | |
18. Recruited to another interventional trial in the previous 6 weeks |