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

NCT04315129 | Completed

• 1 other identifier: 17SM4299
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-Associated Urinary Tract Infection

Keywords

Biosensor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity

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

• Specificity

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

• False Positive Rate

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

• False Negative Rate

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

Study Arms (1)

Single arm

OTHER

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

Interventions

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

Single arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

St Mary's Hospital

London, Greater LOndon, W21Y, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The biosensors will monitor for infections. As this is an unverified, experimental diagnosis, this will not be made available to the patient or care provider. similarly this will not be available to the clinical researchers in order to avoid observation bias. While the participants, providers and investigators will all be aware that the participants have an active biosensor, they will be blinded to the output thereof.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Singlearm blinded study in which biosensor diagnosed infection (experiment) will be compared to clinical diagnosis (control) in a single cohort of surgical patients

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 19, 2020
• Study Start: April 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)