Seasonal Trends in Pneumococcal Carriage in COPD Patients

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT02535546
• Lead Sponsor: Beaumont Hospital

Brief Summary

Patients suffering from chronic obstructive pulmonary disease (COPD) commonly get exacerbations of their illness which have many potential triggers including infection. The most common cause of lung infection/pneumonia is an organism named Streptococcus pneumoniae. In Ireland a 13-valent pneumococcal conjugated vaccine (PCV-13) was recently introduced into the childhood vaccination programme. This study aims to investigate the carriage rate of S. pneumoniae in COPD patients over one year and to determine if isolates of S. pneumoniae found within the COPD population would be covered by the PCV-13 vaccine.

Detailed Description

This study aims to determine the potential contribution of S. pneumoniae to the morbidity of patients with COPD in Ireland and if the PCV-13 has potential for reducing infective exacerbations in this cohort. A group of 150 COPD patients are being monitored at quarterly intervals over one year. At each study visit patients report changes to COPD-related medication, recent hospitalisations and exacerbations and provide a sputum sample (or pharyngeal swab if not possible) which is assessed for the presence of S. pneumoniae.

The specific objectives of the study are:

1. To monitor the carriage rate of pneumococci in a cohort of Irish patients with COPD during and outside periods of acute exacerbation over a one year period.

2. To assess the COPD exacerbation rate amongst this group of patients.

3. To monitor changes in the proportion of patients positive for pneumococci carriage over a full season and to document those patients intermittently or permanently colonised.

4. To characterise S. pneumoniae isolates carried by COPD patients in terms of their genetic evolution, comparison with strains in other countries, and antimicrobial susceptibility.

5. To assess the proportion of colonised COPD patients that would be covered by current and future pneumococcal vaccines.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-28
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Over 18 years of age.
• Have a clinical diagnosis of COPD.
• Have a forced expiratory volume at one second/forced vital capacity (FEV1/FVC) ratio < 80%.

Exclusion Criteria

• Patients too unwell.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carriage rate of Streptococcus pneumoniae in patients with COPD over four seasons.	One year.	Patients with COPD are being monitored over a one year period for carriage of S. pneumoniae. Carriage is determined by analysis of sputum or pharyngeal swab samples which are collected from patients at quarterly intervals.

Secondary Outcome Measures

Name	Time	Method
Characterisation of carriage isolates of Streptococcus pneumoniae from COPD patients.	One year.	Any carriage isolates of S. pneumoniae isolated from COPD patients are assessed for serotype and antibiotic resistance profiles to determine if they are covered by current pneumococcal vaccines.

Trial Locations

Locations (1)

RCSI Education and Research Centre, Beaumont Hospital; 🇮🇪 Dublin 9, Ireland