Seasonal Trends in Pneumococcal Carriage in COPD Patients (Helios)

January 31, 2017 updated by: Professor Richard Costello, Beaumont Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin 9, Ireland
        • RCSI Education and Research Centre, Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

A combination of COPD inpatients and outpatients from Beaumont Hospital, Dublin, Ireland.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Investigators

  • Principal Investigator: Richard Costello, Professor of Respiratory Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeamontH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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