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

NCT01861184 | Completed DMC

• 1 other identifier: 100090090
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lower Respiratory Tract Infections

Keywords

Lower respiratory tract infection; LRTI; Pneumococcal carriage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital with Lower Respiratory Tract Infection

You may qualify if:

• 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

You may not qualify if:

• Infective exacerbation of COPD or bronchiectasis without consolidation Oxygen saturations \<86% on air Tuberculosis suspected Neutropenia
• Able to give fully informed consent (mental capacity assessed using trust guidelines) Age\>18yrs old
• years of recruited LRTI patient Fluent English speaker
• Signs/symptoms of respiratory infection Oxygen saturations \<86% on air Neutropenia

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29992080 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Nasal wash samples Nasopharyngeal swabs (where nasal wash not possible) Urine samples

Study Officials

• Professor Stephen Gordon

  Royal Liverpool University Hospital/ Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 9, 2022

Record last verified: 2013-05

Locations

GB (1)