Incorrect use of antibiotics at a global level has contributed to the growing problem of resistance to multiple antibiotics seen amongst bacteria. The increase in multi-drug resistant bacterial infections over the years has shown an increase in urinary tract infection-related health care utilization, as well as sepsis that is caused by an infection in the urinary tract and death rates. Bloodstream infection incidence is rising globally, and in the UK is caused by an aging population, increased presence of long-term health conditions and increased medical and surgical interventions, along with improved detection.
There are not many studies which have looked at disease progression among women with community-acquired uncomplicated urinary tract infection (uUTI) to assess the prognostic factors for E. coli sepsis, bacteremia, and acute pyelonephritis. Additionally, inappropriate antibiotic treatment of uUTI could be an independent risk factor for E. coli sepsis, bacteremia, or acute pyelonephritis and requires further investigation.
It is important to understand the wider burden of illness arising from uUTI in England. Using retrospective cohort study design, our study will allow for the study of disease progression in uUTI in England and will follow females ≥ 12 years of age with community-acquired uUTI and will examine risk factors of disease progression, inappropriate antibiotic use, as well as quantifying uUTI disease burden, compared to controls.
The study will use retrospective data of English adult and adolescent female patients with linkable Clinical Practice Research Datalink (CPRD)/ Hospital Episode Statistics (HES) data in the period January 1, 2018 through December 31, 2019.The study involves two parts.
Part 1 will use a cohort of adult and adolescent females diagnosed with uUTI caused by E. coli in a community setting (i.e. CPRD) and treated with oral antibiotic and will follow them over their index 28-day uUTI episode. The index uUTI date for the episode will be defined as the date of first uUTI medical code meeting the inclusion/exclusion criteria. This cohort will constitute the main study cohort and is relevant to Objectives 1 and 2.
Part 2 will use a retrospective observational cohort design with matched controls; uUTI patients from Part 1 (cases) will be matched to patients from the general English female population without UTI (controls) to assess the incremental health care burden due to uUTI. This part of the study is relevant to Objective 3.
The outcomes for the study for Objectives 1 and 2 will be HES hospitalization for E coli sepsis, acute pyelonephritis, or bacteremia during the 28-day uUTI episode.
Outcomes for Objective 3 will cover the burden of illness of community-acquired uUTI captured over the 28-day uUTI episode as well as 12 months post-diagnosis:
• Number of all-cause and UTI-specific hospital admissions
• Number of all-cause and UTI-specific admissions to high dependency/intensive treatment unit
• Number of all-cause and UTI-specific Accident and Emergency (A & E) attendances
• Number of all-cause and UTI-specific specialist consultations
• Number of all-cause and UTI-specific primary care (GP) consultations
• Cost of each component of health care resource utilization
Fanny Mitrani-Gold - Chief Investigator - GlaxoSmithKline - USA
Nick Denholm - Corresponding Applicant - Harvey Walsh Ltd
Aruni Mulgirigama - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Ashish Joshi - Collaborator - GlaxoSmithKline - USA
Daniel Gibbons - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
David Heaton - Collaborator - Harvey Walsh Ltd
David Webb - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Mark Wilcox - Collaborator - University of Leeds
Viktor Chirikov - Collaborator - OPEN Health Group
Xiaocong Marston - Collaborator - Harvey Walsh Ltd
Daniel Gibbons - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Matthew O'Connell - Collaborator - Harvey Walsh Ltd
Xiaocong Marston - Collaborator - OPEN Health Group
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Rural-Urban Classification