Experimental human Pneumococcal carriage: Investigating the transmission of pneumococcus bacteria from hand to the nose of healthy adults

Not Applicable

Completed

• Conditions: Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infection prevention; UKCRC code/ Disease: Infection/ Other infectious diseases; Infections and Infestations; Streptococcus pneumoniae

• Registration Number: ISRCTN12909224
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30305331 (added 17/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-06-01
• Study Start: 2017-06-27
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 73

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified