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OpenTrials
Completed

NCT Number: NCT02535546

Seasonal Trends in Pneumococcal Carriage in COPD Patients

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RCSI Education and Research Centre, Beaumont Hospital

Dublin, Ireland

About this study

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:

  • 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.
  • To assess the COPD exacerbation rate amongst this group of patients.
  • 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.
  • To characterise S. pneumoniae isolates carried by COPD patients in terms of their genetic evolution, comparison with strains in other countries, and antimicrobial susceptibility.
  • To assess the proportion of colonised COPD patients that would be covered by current and future pneumococcal vaccines.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Carriage rate of Streptococcus pneumoniae in patients with COPD over four seasons.

    Time frame: 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 outcomes

  1. Characterisation of carriage isolates of Streptococcus pneumoniae from COPD patients.

    Time frame: 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.

Other outcomes

  1. Correlation between seasonality and disease severity in COPD patients.

    Time frame: One year.

    COPD patients are met with at quarterly intervals over one year. At each meeting patients report recent COPD exacerbations, hospitalisations and medication use, as well as scores for disease severity. This data is being used to determine if there is a correlation between disease severity and the seasons in COPD patients.

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Registry information

Official study title

Characterisation of Isolates of Streptococcus Pneumoniae in Patients With Chronic Obstructive Pulmonary Disease

Acronym: Helios

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2015
Registry last updated
Feb 1, 2017

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.

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