Seasonal Trends in Pneumococcal Carriage in COPD Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Chronic Obstructive Pulmonary Disease (COPD)
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Clinical Trial Details

NCT number	NCT02535546
Study type	Observational
Source	Beaumont Hospital
Contact
Status	Completed
Phase	N/A
Start date	July 2014
Completion date	January 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Seasonal Trends in Pneumococcal Carriage in COPD Patients — Helios

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms