ISRCTN12884329Completed未知
The PneumEx study: experimental human pneumococcal challenge and exhaled pneumococcal biomarkers
iverpool School of Tropical Medicine0 sites41 target enrollmentStarted: August 30, 2019Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 41
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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