Pneumonia Respiratory Pneumonia
Conditions
Interventions
Healthy volunteers are randomly allocated to one of two groups. Randomisation is computer-generated and occurs in block sizes of 6. The clinical study team is un-blinded due to the nature of the inter
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-50 years - ages chosen to minimise the risk of pneumococcal infection, and to allow comparison with previously published experimental work done by our group 2. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement 3. Access to mobile telephone – to ensure safety and timely communication 4. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: 1. Previous pneumococcal vaccination 2. History of major pneumococcal illness 3. Close physical contact with at risk individuals (children under 5 years of age, immunosuppressed adults, elderly, chronic ill health) at discretion of the study doctors and/or PI- minimise risk of pneumococcal transmission 4. Allergy to penicillin/amoxicillin and clarithromycin (or other macrolides) 5. Asthma (on regular medications) or chronic respiratory disease – confounding effect of medications such as corticosteroids, and propensity to infection 6. Any acute dermatological illness or skin injury affecting the hands or face at the discretion of the study doctors and/or PI- confounding effects of topical medications and propensity to infection 7. Taking daily medications that may affect the immune system e.g. steroids, steroid nasal spray, antibiotics and roacutanne decision at the discretion of study doctors and PI 8. Current illness, acute illness within 3 days prior to exposure or antibiotic treatment within 2 weeks of exposure 9. Pregnancy - minimise risk of pneumococcal disease 10. Diagnosed as diabetic or any other illness that can affect patients’ immune system- at the discretion of the study doctors and/or PI 11. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase. 12. Have been involved in an EHPC clinical trial involving pneumococcal inoculation/exposure- at the discretion of study team depending on multiple factors attaining to previous study including previous pneumococcal vaccination, time since participation in the study and colonisation status in that study. 13. History of drug or alcohol abuse 14. History of Smoking 14.1.Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease 14.2. Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease 14.3. Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease 14.4. Unable to give fully informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of the exposed pneumococci is measured using classical culture methods at any time point from nasal wash recovered from participants at days 2, 6/7 and 9/10 after first pneumococcal exposure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrence of pneumococcal colonisation determined by the presence of pneumococcus in nasal wash is detected using classical microbiology at each time point post exposure at days 2, 6/7 and 9/10 2. The density of pneumococcal colonisation in nasal wash at each time point following pneumococcal exposure is detected using classical microbiology at days 2, 6/7 and 9/10 3. The area under the curve of pneumococcal colonisation density following pneumococcal exposure is detected using classical microbiology at days 2, 6/7 and 9/10 4. The duration of experimental pneumococcal colonisation determined by the last nasal wash following pneumococcal exposure in which pneumococcus is detected using classical microbiology 5. The occurrence of pneumococcal colonisation determined by the presence of pneumococcus in nasal wash at any time point post exposure up to and including day 9/10, detected using qPCR 6. Endpoints 1-4 detected using qPCR instead of classical microbiology methods | — |
Countries
United Kingdom
Contacts
Public ContactAndrea Collins
Outcome results
None listed