Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection

Study Overview
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Brief Summary
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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
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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?

Official Title
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Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection

Conditions
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Catheter-Associated Urinary Tract Infection

Intervention / Treatment
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* Diagnostic Test: Smart Catheter Biosensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Subjects expected to undergo catheterisation as part of their clinical care. Signed informed consent is a prerequisite for inclusion in the study. Exclusion Criteria: Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>A single arm will have biosensor (experimental) diagnoses compared to clinical (control, current standard of care). All participants in this group willl have a biosensor, with the data masked to patients, providers and clinical researchers | Diagnostic Test: Smart Catheter Biosensor<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time difference of diagnosis | The time difference of biosensor diagnosis of catheter associated UTI as compared to clinical diagnosis (defined as the prescription time of new antimicrobials for suspected UTI) | From the time of catheterisation, until 72hours post-removal of catheters. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The proportion of those subjects who went on to develop CAUTI did the Smart Catheter correctly predict would have CAUTI? | From the time of catheterisation, until 72hours post-removal of catheters. | 
| Specificity | The proportion of those subjects who did not go on to develop CAUTI did the Smart Catheter correctly predict would not have CAUTI. | From the time of catheterisation, until 72hours post-removal of catheters. | 
| False Positive Rate | The proportion of those subjects who would not go on to have CAUTI did the Smart Catheter incorrectly predict would have CAUTI? | From the time of catheterisation, until 72hours post-removal of catheters. | 
| False Negative Rate | The proportion of those subjects who would go on to have CAUTI did the Smart Catheter incorrectly predict would not have CAUTI? | From the time of catheterisation, until 72hours post-removal of catheters. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biosensor