Completed

NCT Number: NCT01861184

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

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).

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Key information

Conditions

Lower Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Rate of pneumococcal carriage in patients hospitalised with LRTI and age matched controls.

Time frame: 6weeks

Pneumococcal colonisation will be defined based on the culture (+/-PCR) result of nasal wash/NPS taken at day 0 and 6 weeks.

Secondary outcomes

Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls

Time frame: 6weeks

Density will be determined using a modified version of Miles and Misra dilutions.

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 23, 2013
Registry last updated: Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed