Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infection prevention
Conditions
Interventions
Healthy non-smoking adult participant’s hands are exposed with well-characterised, fully sequenced penicillin-sensitive pneumococci in order to observe them for the development of pneumococcal carriag
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-50 years (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 their own 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) - minimise risk of pneumococcal transmission 4. Allergy to penicillin/amoxicillin 5. Any current treatment for asthma – confounding effect of medications such as corticosteroids, and propensity to infection 6. Any acute dermatological illness or skin injury affecting the hands or face- 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. 8. Current illness, acute illness within 3 days prior to inoculation or antibiotic treatment within 2 weeks of inoculation 9. Pregnancy - minimise risk of pneumococcal disease 10. Diagnosed as diabetic 11. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase. 12. Have been involved in a EHPC clinical trial involving pneumococcal inoculation in the last 3 years 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 It is anticipated that 10-15% participants of screened participants will have natural pneumococcal colonisation at the time of recruitment as demonstrated by the initial nasal wash. These individuals will be excluded from the study after screening visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 17/09/2018: 1. Detection of 6B pneumococci is measured by using classical culture methods from nasal wash recovered from the participants at days two, six and nine. 2. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months 3. To inform estimation of sample size for a future trial by measuring the colonization rates in one of the four transmission groups in a full cohort of participants Previous primary outcome measure: Detection of 6B pneumococci is measured by using classical culture methods from nasal wash recovered from the participants at days two, six and nine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 17/09/2018 1. Density and duration of pneumococcus carriage is measured using classical culture methods from nasal wash recovered at day 2, 6 and 2. Rate of pneumococcal carriage among participants who were expose to and attempted transmission following drying of the bacterial stock is measured using classical culture methods from nasal wash recovered at day two, six and nine 3. Rate of pneumococcal carriage among participants who were expose to and attempted transmission with wet bacteria stock is measured using classical culture methods from nasal wash recovered at day two, six and nine 4. Assessment of safety of the trial procedures 5. Assessment of any serious concerns about the acceptability of the interventions and feasibility of the trial procedures Previous secondary outcome measures: 1. Density and duration of pneumococcus carriage is measured using classical culture methods from nasal wash recovered at day 2, 6 and 9 2. Rate of pneumococcal carriage among participants who were expose to and attempted transmission following drying of the bacterial stock is measured using classical culture methods from nasal wash recovered at day two, six and nine 3. Rate of pneumococcal carriage among participants who were expose to and attempted transmission with wet bacteria stock is measured using classical culture methods from nasal wash recovered at day two, six and nine | — |
Countries
United Kingdom
Contacts
Public ContactVictoria Connor
Outcome results
None listed