Pneumonia Research: Establishing a Model Using SPN3
- Conditions
- Healthy volunteersNot Applicable
- Registration Number
- ISRCTN11306486
- Lead Sponsor
- iverpool School of Tropical Medicine
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35802840/ (added 11/07/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
1. Healthy young adults aged 18-50 years (inclusive) - ages chosen to minimise the risk of pneumococcal infection, and to allow comparison with previously published experimental work done by our group.
2. Healthy older participants group only- adults aged 60-69 years (inclusive)
3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
4. Access to their own mobile telephone - to ensure safety and timely communication
5. Capacity to give informed consent
1. Currently involved in another study unless observational or non-interventional except for the EHPC bronchoscopy study*
2. Participant in a previous EHPC trial within the last 3 years (at the discretion of the study team ie. Not inoculated nasally with pneumococcus)
3. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in UK babies born since 2005 or US 2001) or PCV10.
4. Allergy: to penicillin or amoxicillin
5. Chronic ill health including, immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease
6. Medication that may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, roacutane) or disease-modifying anti-rheumatoid drugs.
7. Recent antibiotics (within the last 28 days or long term for known active chronic infection)
8. Current illness or acute illness within 14 days prior to inoculation
9. Major pneumococcal illness requiring hospitalisation
10. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
11. Direct caring role or close contact with individuals at higher risk of infection (children under 5 years age, chronic ill health or immunosuppressed adults)
12. Current or ex-smoker (regular cigarettes, regular e-cigarette/vaping and regular smoking of recreational drugs) in the last 6 months
13. Previous significant smoking history - more than 20 cigarettes per day for 20 years or the equivalent (>20 pack years)
14. Women of child-bearing potential (WOCBP) who are:
14.1 Not deemed to have sufficient/effective birth control or confirmed abstinence
14.2 Pregnant
15. History or current drug or alcohol abuse (frequently drinking alcohol: men and women should not regularly drink >3 units/day and >2 units/day respectively) at discretion of the clinician
16. Overseas travel planned in follow up period of the study visits
17. Natural pneumococcal colonisation at baseline It is anticipated that 10-15% 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The presence of SPN3 pneumococcal bacteria in nasal wash recovered by classical microbiological culture at any timepoint post inoculation: Day 2, Day 7 or Day 14. This will be reported as yes or no.
- Secondary Outcome Measures
Name Time Method 1. Density of bacteria recovered from nasal wash by classical microbiological culture in positive participants, this will be reported as colony forming units (CFU) per ml of nasal wash.<br>2. The presence of SPN3 pneumococcal bacteria in nasal wash recovered by molecular methods at any timepoint post inoculation: Day 2, Day 7 or Day 14. This will be reported as yes or no.