NCT02535546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

August 26, 2015

Last Update Submit

January 31, 2017

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease (COPD)Streptococcus pneumoniaePneumoniaPneumococcal conjugate vaccine-13 (PCV-13)Pneumococcal polysaccharide vaccine-23 (PPV-23)Pneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year.

Secondary Outcomes (1)

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

    One year.

Other Outcomes (1)

  • Correlation between seasonality and disease severity in COPD patients.

    One year.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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%.

You may not qualify if:

  • Patients too unwell.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RCSI Education and Research Centre, Beaumont Hospital

Dublin, Ireland

Location

Related Publications (3)

  • 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.

    PMID: 21076929BACKGROUND

  • Vickers 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.

    PMID: 20642870BACKGROUND

  • McCarthy 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.

    PMID: 28694340DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePneumonia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfections

Study Officials

  • Richard Costello

    Professor of Respiratory Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Richard Costello

Study Record Dates

First Submitted

August 26, 2015

First Posted

August 28, 2015

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

IE(1)