Seasonal Trends in Pneumococcal Carriage in COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— Helios  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535546
• Other study ID #: BeamontH
• Status: Completed
• Phase: N/A
• First received: August 26, 2015
• Last updated: January 31, 2017
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Ireland	RCSI Education and Research Centre, Beaumont Hospital	Dublin 9

Sponsors (1)

Lead Sponsor	Collaborator
Beaumont Hospital

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between seasonality and disease severity in COPD patients.	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.
Primary	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	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.	One year.