Perpetual Observational Study on Complicated Urinary Tract Infections

• Research type

  Research Study

• Full title

  Perpetual Observational Study on Complicated Urinary Tract Infections

• IRAS ID

  317548

• Sponsor organisation

  University Medical Center Utrecht

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  Complicated urinary tract infections (cUTI) are associated with significant morbidity and mortality. Due to the high frequency of UTI, they have a major impact on antibiotic use and the antibiotic resistance of prominent UTI bacteria is of recognised importance. Therefore, UTIs, and particularly cUTIs, are a target for repurposing of old and neglected drugs, new drug development and non-antibiotic therapeutic and preventive approaches.
  The objectives of this multinational prospective observational cohort study are to:
  • continuously evaluate best practices related to patient enrolment and data collection to improve study execution
  • collect information to support the design of innovative clinical trials and population enrichment.
  • determine the incidence of treatment failure in patients with cUTI
  • determine modifiable and non-modifiable risk factors for treatment failure in patients with cUTI
  • describe the patient population with cUTI and the microbiological causes of cUTI in the study sites
  • determine the rate of recurrences and superinfections, and those caused by multidrug-resistant bacteria
  • determine the mortality and its predictors in patients with cUTI
  • determine the length of hospital stay after cUTI
  • investigate outcomes (treatment failure and mortality) and outcome predictors in subgroup of patients, including elderly patients, patients with urinary catheters, patients with bacteria in their blood, intensive care patients, patients with hospital-acquired cUTI, patients with multidrug-resistant bacteria
  • describe variations in current practices in treating cUTI in the study sites
  The study will take place recruiting 16,000 patients in 40 sites across 10-20 European countries over a 4 year period. Any patient ≥18 years of age with a cUTI can be enrolled and studied for 30 days post-diagnosis.
  Exclusions include patients who:
  • are expected to survive for <30 days or are exclusively for palliative care
  • die <48 hours after diagnosis
  • are participating in an trial for treatment of cUTI
  • were diagnosed with cUTI more than 96 hours previously.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  22/NE/0215

• Date of REC Opinion

  24 Nov 2022

• REC opinion

  Favourable Opinion