Streptococcus pneumoniae infection in smokers and people with chronic obstructive pulmonary disease (COPD) Infections and Infestations
Conditions
Interventions
Duration 24 months
Type Cohort study of human participants divided into 2 groups:
Group 1: Participants that smoke - regularly smoke a mean average of =5 cigarettes per
Sponsors
Liverpool School of Tropical Medicine (LSTM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy cigarette smokers: 1. Adults aged 18 - 50 years 2. Current regular cigarette smoker - smoking a mean average =5 cigarettes per day for the preceding 3 months 3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement 4. Access to telephone (safety and timely communication) 5. Capacity to give informed consent Inclusion criteria for COPD patients: 1. Adults aged 50 - 84 years 2. Either a current regular cigarette smoker - smoking a mean average =5 cigarettes per day for the preceding 3 months (SMOKER) or an ex-smoker - no regular e-cigarette, vaping or cigarette smoking in the preceding 3 months 3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement 4. Access to telephone (safety and timely communication) 5. Diagnosis of COPD defined by Spirometry as FEV1/FVC ratio < 0.7 (post bronchodilator) 6. Capacity to give informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for Group 1 and 2: 1. In a caring role or with intimate physical contact with at-risk individuals (children under 5yrs, immunosuppressed adults) during the period of pneumococcal colonisation 2. History of or current regular drug or alcohol abuse (frequently drinking alcohol: men and women should not regularly drink > 3-4 units/day and > 2-3 units/day respectively) 3. Taking daily medications that may affect the immune system e.g. systemic steroids, systemic corticosteroids, antibiotics, or disease-modifying anti-rheumatoid drugs 4. Any acute illness (new symptoms within preceding 14 days which are unexplained by the known past medical history) 5. Having received any antibiotics in the preceding 28 days 6. History of culture-proven pneumococcal disease 7. Involved in another clinical trial unless observational or in follow-up (non-interventional) phase 8. Have been involved in a clinical trial involving EHPC and bacterial inoculation in the past three years 9. Disease associated with altered immunity, including diabetes, alcohol abuse, malignancy, rheumatological conditions 10. At the clinician’s discretion any unstable or poorly controlled co-morbidity 11. Taking medication that affects blood clotting (except aspirin and clopidogrel) e.g. warfarin or other oral or injectable anticoagulants 12. Have any uncontrolled medical/ surgical conditions such as but not restricted to: hypertension, mental health conditions, epilepsy, narcolepsy, chronic conditions requiring pain medication such as osteoarthritis, skin conditions, allergies, hay fever, and any other condition at the discretion of the PI 13. Allergy to penicillin/amoxicillin AND clarithromycin 14. Concern of the study doctor about the participant’s health Exclusion criteria for healthy cigarette smokers: 1. > = 20 pack year smoking history Exclusion criteria for COPD patients: 1. 15% of the baseline FEV1 suggests a diagnosis of asthma and would lead to exclusion from the study 4. Acute exacerbation of COPD in the last 3 months or more than 3 exacerbations in the last 12 months requiring oral steroids and/or hospitalisation 5. On ambulatory or long-term oxygen therapy 6. Significant cardiorespiratory disease, other than COPD (excluding stable hypertension) 7. Definite diagnosis of pre-existing asthma (excluding childhood asthma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colonisation of SPN6 post inoculation; Timepoint(s): At any timepoint post inoculation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The presence of pneumococcal bacteria in nasal wash, detected by classical microbiological and molecular methods at any timepoint post challenge 2. Cell populations and counts measured using flow cytometry from nasal samples pre and post challenge 3. Antibody levels measured in serum and nasal wash samples pre and post challenge 4. The pneumococcal killing will be measured by counting the recovered pneumococcal bacteria following incubation with the neutrophils compared to bacteria that were not incubated with neutrophils 5. Daily symptoms will be recorded using a Likert scale for 7 days post challenge | — |
Countries
England, United Kingdom
Outcome results
None listed