Chronic Obstructive Pulmonary Disease (COPD)HeliosNCT02535546
Seasonal Trends in Pneumococcal Carriage in COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Beaumont Hospital at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A combination of COPD inpatients and outpatients from Beaumont Hospital, Dublin, Ireland.
Who may be able to join
- 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%.
Who cannot join
- Patients too unwell.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Keywords
- Chronic obstructive pulmonary disease (COPD), Streptococcus pneumoniae, Pneumonia, Pneumococcal conjugate vaccine-13 (PCV-13), Pneumococcal polysaccharide vaccine-23 (PPV-23), Pneumococcal vaccine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Carriage rate of Streptococcus pneumoniae in patients with COPD over four seasons.
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.
Measured: One year.
Secondary outcomes (1)
Characterisation of carriage isolates of Streptococcus pneumoniae from COPD patients.
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.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard Costello, Principal investigator, Professor of Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535546
- Sponsor's protocol ID
- BeamontH
- Acronym
- Helios
- Status last verified
- Jan 2017
- First submitted
- 26 Aug 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vickers I, O'Flanagan D, Cafferkey M, Humphreys H. Multiplex PCR to determine Streptococcus pneumoniae serotypes causing otitis media in the Republic of Ireland with further characterisation of antimicrobial susceptibilities and genotypes. Eur J Clin Microbiol Infect Dis. 2011 Mar;30(3):447-53. doi: 10.1007/s10096-010-1108-7. Epub 2010 Nov 13.
PubMed 21076929Vickers I, Fitzgerald M, Murchan S, Cotter S, O'Flanagan D, Cafferkey M, Humphreys H. Serotype distribution of Streptococcus pneumoniae causing invasive disease in the Republic of Ireland. Epidemiol Infect. 2011 May;139(5):783-90. doi: 10.1017/S0950268810001743. Epub 2010 Jul 19.
PubMed 20642870McCarthy H, Jackson M, Corcoran M, McElligott M, MacHale E, Sulaiman I, Cushen B, Costello RW, Humpreys H. Colonisation of Irish patients with chronic obstructive pulmonary disease by Streptococcus pneumoniae and analysis of the pneumococcal vaccine coverage: a non-interventional, observational, prospective cohort study. BMJ Open. 2017 Jul 9;7(7):e013944. doi: 10.1136/bmjopen-2016-013944.
PubMed 28694340
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Isolates of Streptococcus Pneumoniae in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02535546
- Acronym / sponsor ID
- Helios / BeamontH
- Keywords
- Chronic obstructive pulmonary disease (COPD), Streptococcus pneumoniae, Pneumonia, Pneumococcal conjugate vaccine-13 (PCV-13), Pneumococcal polysaccharide vaccine-23 (PPV-23), Pneumococcal vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A combination of COPD inpatients and outpatients from Beaumont Hospital, Dublin, Ireland.
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (1 listed)
- Patients too unwell.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Characterisation of carriage isolates of Streptococcus pneumoniae from COPD patients.
Time frame: One year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 21076929Vickers I, O'Flanagan D, Cafferkey M, Humphreys H. Multiplex PCR to determine Streptococcus pneumoniae serotypes causing otitis media in the Republic of Ireland with further characterisation of antimicrobial susceptibilities and genotypes. Eur J Clin Microbiol Infect Dis. 2011 Mar;30(3):447-53. doi: 10.1007/s10096-010-1108-7. Epub 2010 Nov 13.
- Background: PubMed 20642870Vickers I, Fitzgerald M, Murchan S, Cotter S, O'Flanagan D, Cafferkey M, Humphreys H. Serotype distribution of Streptococcus pneumoniae causing invasive disease in the Republic of Ireland. Epidemiol Infect. 2011 May;139(5):783-90. doi: 10.1017/S0950268810001743. Epub 2010 Jul 19.
- Derived from this study: PubMed 28694340McCarthy H, Jackson M, Corcoran M, McElligott M, MacHale E, Sulaiman I, Cushen B, Costello RW, Humpreys H. Colonisation of Irish patients with chronic obstructive pulmonary disease by Streptococcus pneumoniae and analysis of the pneumococcal vaccine coverage: a non-interventional, observational, prospective cohort study. BMJ Open. 2017 Jul 9;7(7):e013944. doi: 10.1136/bmjopen-2016-013944.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Costello principal investigator
Professor of Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carriage rate of Streptococcus pneumoniae in patients with COPD over four seasons. (time frame: One year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535546, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.