Pneumococcal Carriage in Patients With Lower Respiratory Tract Infection (LRTI)

Study Overview
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Brief Summary
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We are interested in developing new and better ways of diagnosing the cause of lower respiratory tract infections including pneumonia. Currently we find the causal bug (bacteria or virus) in less than 50% of patients with pneumonia. A potential way to better find the bug responsible may include checking for bugs in the nose by a nasal wash or swab. Better diagnostics would allow more targeted antibiotic therapy and in the future this technique may be used as a way of checking the efficiency of new vaccines. We are recruiting both patients with respiratory infections and also a 'control' group of patients admitted to hospital who do not have respiratory infection. We need to have access to your medical history information to make sure you are eligible and suitable for the study. If you participate in the study, it is important that the study doctors continue to have access to your personal Investigator Designation Contact telephone Dr Andrea Collins PhD student/research SpR xxxxxxxxxxxxx Carole Hancock Research nurse 0151 706 4856 Prof Stephen Gordon Principle Investigator 0151 705 3169 NW PIL V1.3: October 2012 REC ref: 12/NW/0713 information so you can be followed up properly and so we can contact you during the study if needed. Patients in both groups will have a nasal wash (or swab), blood (30mls = 6 teaspoons) and urine taken on the day of recruitment and a nasal wash (or swab) and blood (30mls = 6 teaspoons) taken 6 weeks later (this is likely to be as an out-patient at the Royal Liverpool, in extreme circumstances this will occur at the patient's home).

Detailed Description
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STUDY DESIGN OVERVIEW Overall research aim To analyse pneumococcal carriage rates in patients hospitalised with LRTI. Primary endpoint Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls. Secondary endpoints Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls Alterations of T cell function (Th1, Th17, T regs) in LRTI patients and age matched controls (versus younger adults as part of our existing 'P4' study). Study design Patients hospitalised with LRTI between November 2012 and April 2014 will be approached within 72 hours of admission. Patients recruited into the study will consist of those hospitalised with LRTI and a control group of age matched patients (within +/- 10 years) hospitalised for reasons other than respiratory infection.

Official Title
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A Study of Pneumococcal Carriage in Hospitalised Patients With Lower Respiratory Tract Infections

Conditions
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Lower Respiratory Tract Infections

Participation Criteria
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Eligibility Criteria
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Inclusion criteria for LRTI patients: Non-pneumonic LRTI (no radiological consolidation but the presence of clinical signs) or community acquired pneumonia (radiological consolidation) Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker Exclusion criteria for LRTI patients: Infective exacerbation of COPD or bronchiectasis without consolidation Oxygen saturations <86% on air Tuberculosis suspected Neutropenia Inclusion criteria for controls: Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old 10 years of recruited LRTI patient Fluent English speaker Exclusion criteria for controls: Signs/symptoms of respiratory infection Oxygen saturations <86% on air Neutropenia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LRTI group<br>Non-pneumonic LRTI (no radiological consolidation but the presence of clinical signs) or community acquired pneumonia (radiological consolidation) Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker | |
| Control group<br>Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls. | Pneumococcal colonisation will be defined based on the culture (+/-PCR) result of nasal wash/NPS taken at day 0 and 6 weeks. | 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls | Density will be determined using a modified version of Miles and Misra dilutions. | 6weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LRTI, Lower respiratory tract infection, Pneumococcal carriage