Catheter-Associated Urinary Tract InfectionNCT04315129
Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
A study testing Smart Catheter Biosensor in people with Catheter-Associated Urinary Tract Infection, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Catheter-Associated Urinary Tract Infection
- What is being tested?
- Smart Catheter Biosensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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?"
- Being tested
- Smart Catheter Biosensor
- Keywords
- Biosensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Catheter BiosensorDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Smart Catheter Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the time of catheterisation, until 72hours post-removal of catheters.
Secondary outcomes (4)
Sensitivity
The proportion of those subjects who went on to develop CAUTI did the Smart Catheter correctly predict would have CAUTI?
Measured: 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.
Measured: 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?
Measured: 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?
Measured: From the time of catheterisation, until 72hours post-removal of catheters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Apr 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Associated Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315129
- Sponsor's protocol ID
- 17SM4299
- Status last verified
- Sep 2021
- First submitted
- 18 Mar 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant Data is confidential and will to be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Catheter: A Novel Biosensor for Early Detection of Catheter Associated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT04315129
- Acronym / sponsor ID
- 17SM4299
- Keywords
- Biosensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?"
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Diagnostic Test: Smart Catheter BiosensorA 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Consent to participate not given Known sensitivity to urinary catheters or electronic products Patients undergoing urologic procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Catheter BiosensorA 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 | Diagnostic test | Single arm |
Primary outcome
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)
4 secondary outcomes
Sensitivity
Time frame: From the time of catheterisation, until 72hours post-removal of catheters.
Specificity
Time frame: From the time of catheterisation, until 72hours post-removal of catheters.
False Positive Rate
Time frame: From the time of catheterisation, until 72hours post-removal of catheters.
False Negative Rate
Time frame: From the time of catheterisation, until 72hours post-removal of catheters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No. Participant Data is confidential and will to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Catheter Biosensor in people with Catheter-Associated Urinary Tract Infection, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time difference of diagnosis (time frame: From the time of catheterisation, until 72hours post-removal of catheters.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.