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Completed

NCT Number: NCT04315129

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

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.

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Key information

Conditions

Catheter-Associated Urinary Tract Infection

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's Hospital

London, Greater LOndon, W21Y, United Kingdom

About this study

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?"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart Catheter Biosensor

Diagnostic Test

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

Primary outcomes

  1. Time difference of diagnosis

    Time frame: From the time of catheterisation, until 72hours post-removal of catheters.

    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)

Secondary outcomes

  1. Sensitivity

    Time frame: From the time of catheterisation, until 72hours post-removal of catheters.

    The proportion of those subjects who went on to develop CAUTI did the Smart Catheter correctly predict would have CAUTI?

  2. Specificity

    Time frame: From the time of catheterisation, until 72hours post-removal of catheters.

    The proportion of those subjects who did not go on to develop CAUTI did the Smart Catheter correctly predict would not have CAUTI.

  3. False Positive Rate

    Time frame: From the time of catheterisation, until 72hours post-removal of catheters.

    The proportion of those subjects who would not go on to have CAUTI did the Smart Catheter incorrectly predict would have CAUTI?

  4. False Negative Rate

    Time frame: From the time of catheterisation, until 72hours post-removal of catheters.

    The proportion of those subjects who would go on to have CAUTI did the Smart Catheter incorrectly predict would not have CAUTI?

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2020
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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