Hand washing study

Not Applicable

Completed

• Conditions: Pneumonia; Respiratory

• Registration Number: ISRCTN13025191
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-02
• Study Completion: 2018-06-07
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 179

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.