Healthy volunteers. Prevention of respiratory infection. Infections and Infestations
Conditions
Interventions
Healthy volunteers are randomised to wash their hands or not wash their hands after pneumococcal bacteria is placed on their hands. They are all then asked to transmit the bacteria by wiping their nos
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. Speak fluent 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 15.Current regular smoker (smokes daily/ smokes > 5 cigarettes per week) - minimise risk of pneumococcal disease 16.Recent smoker i.e. within the last 6 months - minimise risk of pneumococcal disease 17.Ex-smoker with a significant smoking history (>10 pack years) – minimise risk of pneumococcal disease 18.Unable to give fully informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The presence of pneumococcal bacteria in the nose following exposure using classical microbiological methods. Nasal wash samples are taken pre-exposure, day 2, day 6/7 and day 9/10. Pneumococcal bacteria serotype is confirmed by a commercially available latex agglutination kit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The presence of pneumococcal bacteria in the nose following exposure using molecular methods (LytA PCR). Nasal wash samples are taken pre-exposure, day 2, day 6/7 and day 9/10. 2.The density of the bacteria in the nose following exposure.Density of bacteria is confirmed by counting the 6B pneumococcal colonies present in the nasal wash samples at day 2, 6/7 and 9/10. | — |
Countries
England, United Kingdom
Contacts
Public ContactAngela Hyder-Wright
Outcome results
None listed