Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
Condition: Catheter-Associated Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      Urinary Tract Infection (UTI) is the most common hospital acquired infection worldwide, and
      is most commonly associated with catheterisation of the bladder. Catheter associated urinary
      tract infection (CAUTI) causes increased hospital costs, increased length of stay and
      increased mortality. This burden of disease is, in part, mediated by a lack of diagnostic and
      monitoring modalities for CAUTI. Both traditional and novel UTI diagnostic tests are
      susceptible to false positives associated with bacterial colonisation, and correlate poorly
      with clinically meaningful symptomatic CAUTI. As such, the current standard of care is
      reliant on clinical monitoring, which is susceptible to diagnostic delays, over and under
      treatment.

      Imperial College London have developed a wireless biosensor for continuous monitoring of
      catheter-urine biochemistry. This project aims to validate this biosensor and demonstrate
      it's potential for preemptive CAUTI diagnosis through continuous urinary biochemical
      monitoring.
    

Detailed description: 
      This research project aims to demonstrate that continuous urinary biochemical monitoring
      using a Smart Catheter biosensor can provide rapid diagnosis of impending catheter associated
      urinary tract infection (CAUTI). The primary research question will then be: "Does the Smart
      Catheter device reduce the time to diagnosis of CAUTI?"

      This will be accomplished through four studies: The aim of the first study will be to show
      the reliability and robustness of the Smart Catheter device through the question: "Is there
      any difference between the biochemical measurements from the Smart catheter device and a
      gold-standard laboratory measurement?"

      The aim of the second and third studies aim to demonstrate the different biochemical profiles
      of infected and healthy urine by addressing the research question: "What is the difference in
      biochemical concentrations in healthy urine as compared to infected urine?" Study 3 will
      accomplish this by comparing infected human catheter-acquired urine as compared to uninfected
      human catheter-urine. Study 3 will monitor the changes in biochemical changes in an artifical
      bladder with artificial urine over time while an infection is induced.

      The final study will demonstrate the reduced time to diagnosis in a clinical setting by
      addressing the research question: " What is the time difference in diagnosis of CAUTI from
      the CAUTI as compared to the current standard of clinical monitoring?"
    

Intervention name(s): Smart Catheter Biosensor
Intervention type(s): Diagnostic Test
Intervention description(s): A novel biosensor in-built into the catheter drainage system that monitors the chemical composition of the urine, with the intention of providing early diagnosis of developing infection
Intervention model: Single Group Assignment
Intervention model description: Singlearm blinded study in which biosensor diagnosed infection (experiment) will be compared to clinical diagnosis (control) in a single cohort of surgical patients
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Biosensor