Clinical trial NCT02535546: Seasonal Trends in Pneumococcal Carriage in COPD Patients
Official title: Characterisation of Isolates of Streptococcus Pneumoniae in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD)
Streptococcus pneumoniae
Pneumonia
Pneumococcal conjugate vaccine-13 (PCV-13)
Pneumococcal polysaccharide vaccine-23 (PPV-23)
Pneumococcal vaccine
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A combination of COPD inpatients and outpatients from Beaumont Hospital, Dublin, Ireland.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Carriage rate of Streptococcus pneumoniae in patients with COPD over four seasons.
timeFrame: One year.
Secondary outcomes:
measure: Characterisation of carriage isolates of Streptococcus pneumoniae from COPD patients.
timeFrame: One year.
Other outcomes:
measure: Correlation between seasonality and disease severity in COPD patients.
timeFrame: One year.
Locations:
city: Dublin 9
country: Ireland
facility: RCSI Education and Research Centre, Beaumont Hospital
Study officials:
affiliation: Professor of Respiratory Medicine
name: Richard Costello
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2010 Nov 13.
citation: 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.
citation: 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.