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

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

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).

Study Overview

• Status: Completed
• Conditions: Lower Respiratory Tract Infections

Detailed Description

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

1. Density of pneumococcal carriage in patients hospitalised with LRTI and age matched controls
2. 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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital with Lower Respiratory Tract Infection

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LRTI group; 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; Able to give fully informed consent (mental capacity assessed using trust guidelines) Age>18yrs old Fluent English speaker

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Professor Stephen Gordon, Royal Liverpool University Hospital/ Liverpool School of Tropical Medicine

Publications and helpful links

General Publications

• German EL, Al-Hakim B, Mitsi E, Pennington SH, Gritzfeld JF, Hyder-Wright AD, Banyard A, Gordon SB, Collins AM, Ferreira DM. Anti-protein immunoglobulin M responses to pneumococcus are not associated with aging. Pneumonia (Nathan). 2018 Jun 5;10:5. doi: 10.1186/s41479-018-0048-3. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: LRTI; Lower respiratory tract infection; Pneumococcal carriage
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 100090090

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No