Examining exhaled breath for the presence of the bacteria pneumococcus

Not Applicable

Completed

• Conditions: asopharyngeal colonisation by pneumococcus; Infections and Infestations

• Registration Number: ISRCTN12884329
• 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: 2019-08-30
• Study Completion: 2021-04-01
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Adults aged 18-50 years
2. Fluent spoken English
3. Access to mobile telephone – to ensure safety and timely communication
4. Capacity to give informed consent

Exclusion Criteria

1. Research participant:
1.1. Currently involved in another study unless observational or non-interventional except for the EHPC bronchoscopy study
1.2. Participant in a previous EHPC trial within the last 3 years (at the discretion of the study team, i.e. not inoculated nasally with pneumococcus)
2. Vaccination: previous pneumococcal vaccination PPV23 or PCV13 (routine in UK babies born since 2005 or US 2001)
3. Allergy: to penicillin/amoxicillin and clarithromycin (or other macrolides)
4. Health history:
4.1. Chronic ill health including immunosuppressive history, diabetes, asthma (on regular medication), recurrent otitis media or other respiratory disease
4.2. Medication that may affect the immune system e.g. steroids, inflammation altering (e.g. nasal steroids, roacutane) or disease-modifying anti-rheumatoid drugs.
4.3. Recent antibiotics (within the last 28 days or long term for known active chronic infection)
4.4. Current illness or acute illness within 14 days prior to inoculation
4.5. Major pneumococcal illness requiring hospitalisation
4.6. Other conditions considered by the clinical team as a concern for participant safety or integrity of the study
5. Direct caring role or close contact: with individuals at higher risk of infection:
5.1. Children under 5 years age
5.2. Chronic ill health or immunosuppressed adults
6. Smoker:
6.1. Current or ex-smoker (regular cigarettes, regular e-cigarette/vaping and regular smoking of recreational drugs) in the last 6 months
6.2. Previous significant smoking history - more than 20 cigarettes per day for 20 years or the equivalent (>20 pack years)
7. Women of childbearing potential (WOCBP): who are:
7.1. Not deemed to have sufficient/effective birth control or confirmed abstinence
7.2. Pregnant
8. 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 the discretion of the clinician
9. Overseas travel planned in the follow-up period of the study visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified