Clinical trial NCT04315129: Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
Official title: Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Associated Urinary Tract Infection
Keywords: Biosensor
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: DIAGNOSTIC

Brief 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?"

Eligibility criteria: 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

Primary outcomes:
measure: Time difference of diagnosis
timeFrame: From the time of catheterisation, until 72hours post-removal of catheters.
Secondary outcomes:
measure: Sensitivity
timeFrame: From the time of catheterisation, until 72hours post-removal of catheters.
measure: Specificity
timeFrame: From the time of catheterisation, until 72hours post-removal of catheters.
measure: False Positive Rate
timeFrame: From the time of catheterisation, until 72hours post-removal of catheters.
measure: False Negative Rate
timeFrame: From the time of catheterisation, until 72hours post-removal of catheters.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
state: Greater LOndon
Study officials:
References: