Epidemiology study of Invasive Extra-Intestinal pathogenic Escherichia coli (ExPEC) Disease in adults and elderly using real world healthcare databases

Study type
Protocol
Date of Approval
Study reference ID
17_287
Lay Summary

Escherichia coli bacterial infections of sites in the body that are normally free of bacteria, referred to as Invasive Extra-Intestinal pathogenic E. Coli Disease (IED), is a major public health concern. E. Coli bacteria are the main cause of urinary tract infections, and can also lead to infections of the bloodstream, pneumonia, and meningitis. The frequency, complications (e.g., death), and groups most at risk of IED, are not well understood however. This study therefore aims to estimate the frequency of IED in the general population, as well as in sub-groups of interest, defined by risk factors for this disease, such as age, other diseases (e.g., diabetes), and surgical procedures. Additionally, the study will explore the risk of death among adults with IED, overall and within specific at-risk groups. Real world healthcare data, as will be used in this study, can provide much needed information on IED occurrence and persons at risk, thereby informing about the design of research studies to develop potential vaccines to protect from IED.

Technical Summary

Extra-intestinal pathogenic Escherichia coli (ExPEC) are the main cause of urinary tract infections (UTIs) and also commonly lead to other infections such as bloodstream infections, meningitis, and pneumonia. E. coli infections of sterile sites, referred to as Invasive ExPEC Disease (IED), is a notable public health problem. The objective of this primarily descriptive study is to generate evidence on IED epidemiology in adults, especially the elderly, from a high income country. We will conduct an observational, retrospective cohort study using health-records of the CPRD population eligible for linkage with HES Admitted Patient Care, ONS Death Registration Data, and HES Outpatient from 1st January 2000 to the latest CPRD release available at the time of analyses. We will estimate the frequency (incidence rate) of IED in the study population, as well as in specific sub-groups, defined by disease risk factors, such as demographic variables (e.g., age), chronic medical conditions (e.g., type 2 diabetes mellitus, chronic kidney disease), acute medical events (e.g., UTI), and medical interventions (e.g., indwelling urinary catheters, surgical procedures). We will also calculate the mortality rate related to IED and the proportion of cases who die during the study period.

Health Outcomes to be Measured

IED (incidence rate); Death (crude mortality rate, case fatality rate).

Collaborators

Eva Herweijer - Chief Investigator - Cytel Statistical Services and Software UK Limited
Eva Herweijer - Corresponding Applicant - Cytel Statistical Services and Software UK Limited
Alan Johnson - Collaborator - Public Health England
Germano Ferreira - Collaborator - Not from an Organisation
Kaatje Bollaerts - Collaborator - P95
Russell Hope - Collaborator - Public Health England
Thomas Verstraeten - Collaborator - P95

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation