An interventional study of Smart Catheter Biosensor in Catheter-Associated Urinary Tract Infection, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic
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.
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?"
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
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
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
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)
Time frame: From the time of catheterisation, until 72hours post-removal of catheters.
Sensitivity
The proportion of those subjects who went on to develop CAUTI did the Smart Catheter correctly predict would have CAUTI?
Time frame: 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.
Time frame: 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?
Time frame: 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?
Time frame: From the time of catheterisation, until 72hours post-removal of catheters.
Plan to share: No — Participant Data is confidential and will to be shared
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Imperial College London