Bacterial Urinary Tract InfectionMicroUDxTMNCT04228081
MicroUDxTM: a Rapid Diagnostic Tool That Will Prevent Death and Disability From Common Infections
An observational study of Bacterial Urinary Tract Infection, run by University of Calgary at 1 site in Canada.
Trial summary
Background \& Rational: Antibiotics are a major underpinning of modern medicine. The global rise of antimicrobial resistant (AMR) organisms is a serious world health problem. With few new antimicrobial drugs on the horizon, it is imperative that we develop novel approaches to extend the service life of our existing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Urinary Tract Infection
- How many people
- 10,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 15 Oct 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The majority of urine samples collected in Calgary coming from young healthy females with symptoms of cystitis or pyelonephritis. However, residual sample from any patient where a urine culture has been ordered could be included in the study if it falls within the time during which residual samples are being processed.
Who may be able to join
- Patients who have not submitted urine samples will not be included as the samples are required for both standard testing and research. This would include patients who are being treated empirically by physicians.
Who cannot join
- Patient's who have not submitted urine samples for culture will not be included in study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary
Calgary, Alberta, T2N 1N4
Ian A Lewis, PhD, 403-220-4366, ian.lewis2@ucalgary.ca
Troy D Feener, MSc, 403-870-1201, tdfeener@ucalgary.ca
About this study
Official title: The Development of a Rapid and Accurate Method for Detecting and Susceptibility Testing of Bacteria Causing Urinary Tract Infection Using a Metabolomic Platform
Background \& Rational:
Antibiotics are a major underpinning of modern medicine. The global rise of antimicrobial resistant (AMR) organisms is a serious world health problem. With few new antimicrobial drugs on the horizon, it is imperative that we develop novel approaches to extend the service life of our existing drugs. AMR is a complex problem that is being driven by a wide range of factors. More than half of the antibiotics prescribed have no medical benefit, and outpatient visits for uncomplicated urinary tract infections (UTIs) are a major contributor to this problem. Recent studies have shown that nearly half of people treated for UTIs receive the wrong frontline drug and in 75% of patients, the duration of therapy is inappropriate. Limitations in the current diagnostic technology make it impossible to identify UTI pathogens and measure their antibiotic sensitivities during the short out-patient clinical visits that are typical for most UTI patients. These circumstances result in the inappropriate use of stronger than necessary or inappropriate antimicrobials. The aim of this study is to develop and evaluate a system that can detect bacteria in urine and find the best antibiotic in under 4 hours, thus enabling a rapid diagnosis and use of the most appropriate and cost-effective antimicrobial agent for the agent detected.
Read the detailed description
Testing done in this study will be performed either on bacterial isolates stored in the microbiology laboratory at the Diagnostic and Scientific Center in Calgary, or on up to one milliliter of residual urine sample submitted to the diagnostic laboratory with a request for urine culture and sensitivity. All urine cultures will be performed and reported in accordance with standards laboratory protocols. Research testing will only be done on residual sample once patient samples are processed or reported on for clinical purposes.
During the first phase of the study, metabolic biomarkers for uropathogens will be identified using mass spectrometry on sub-cultures of frozen isolates from the diagnostic microbiology laboratory. This will include at least 50 isolates each of uropathogens consisting of but not limited to Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterobacter species, Proteus mirabilis, Citrobacter species, Staphylococcus aureus, Staphylococcus saprophyticus, Pseudomonas aeruginosa, Enterococcus species, and Candida species. Biomarkers that are present in greater than 95% of the isolates will subsequently be using the analysis of 2000 negative, and 2000 positive urine cultures. Compounds that are subsequently identified as high yield will be selected for carbon 13 labeling to service standards.
In phase II of the study, following the development of a biomarker enrichment device at the CMRF, a performance urinalysis of the device will be conducted using residual urine sample from 1000 negative and 2000 positive urine specimens as outlined above. The performance of the new device will be evaluated relative to standard cultures and urine liquid chromatography-mass spectrometry.
Following the creation of a sensitive and specific assay, a prospective study will be carried out at the diagnostic microbiology laboratory. 3000 sample submitted for urine culture will be process in parallel with the new device and standard microbiology procedures. Sensitivity, specificity and predictive value for each analyte compared to standard culture will be determined in this portion of the study. Cost calculations and performance characteristics including turnaround time of the new assay will be compared to that in the standard laboratory procedure.
- Conditions
- Bacterial Urinary Tract Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UTI Positive | In phase I of the study testing residual urine samples the aim is to include at least 50 positive samples from each bacterial species known to be commonly associated with urinary tract infections. We selected 2000 positive urines to enable capturing enough of these organisms in the development process. For phase II of the study, the same number of positive samples in order to include all common species causing urinary tract infection. The number of negative samples included is reduced to 1000. Phase 3 - approximately one third of all urine sample submitted will be positive for a uropathogen. Sample size of 3000 we expect 1000 these to be culture positive. We expect most uropathogens occurring at a frequency of 5% or more will be included with sufficient numbers in the validation process. | |
| UTI Negative Control | 2000 negative urine samples are being run as controlled to ensure the false positivity rate is low. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assay ID Validation
In the validation phase of the study sensitivity, specificity and positive and negative predictive values for detecting significant bacteriuria using culture as the gold standard, These values will be calculated for the whole cohort as per standard definitions using statistical software (Analyse-it for Excel).
Measured: 2 years
Secondary outcomes (2)
Susceptibility - anti-microbial susceptibility of new assay versus standard laboratory methods
A secondary outcome variable will be the detection of antimicrobial susceptibility using the new assay will be the calculation of essential and categorical agreement, major, very major and minor errors between the new assay and standard laboratory methods as per standard laboratory definitions.
Measured: 2 years
Turn-around-time to bacterial detection and susceptibility
Another secondary outcome will be the turn-around- time (TAT) to bacterial detection and availability of susceptibility results.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Principal investigator, Ian Lewis, University of Calgary
- Investigators
- Ian A Lewis, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228081
- Sponsor's protocol ID
- REB19-00442
- Acronym
- MicroUDxTM
- Status last verified
- May 2022
- First submitted
- 10 Jan 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Rapid and Accurate Method for Detecting and Susceptibility Testing of Bacteria Causing Urinary Tract Infection Using a Metabolomic Platform
- ClinicalTrials.gov ID
- NCT04228081
- Acronym / sponsor ID
- MicroUDxTM / REB19-00442
- Conditions
- Bacterial Urinary Tract Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 14 Jan 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.
Background \& Rational:
Antibiotics are a major underpinning of modern medicine. The global rise of antimicrobial resistant (AMR) organisms is a serious world health problem. With few new antimicrobial drugs on the horizon, it is imperative that we develop novel approaches to extend the service life of our existing drugs. AMR is a complex problem that is being driven by a wide range of factors. More than half of the antibiotics prescribed have no medical benefit, and outpatient visits for uncomplicated urinary tract infections (UTIs) are a major contributor to this problem. Recent studies have shown that nearly half of people treated for UTIs receive the wrong frontline drug and in 75% of patients, the duration of therapy is inappropriate. Limitations in the current diagnostic technology make it impossible to identify UTI pathogens and measure their antibiotic sensitivities during the short out-patient clinical visits that are typical for most UTI patients. These circumstances result in the inappropriate use of stronger than necessary or inappropriate antimicrobials. The aim of this study is to develop and evaluate a system that can detect bacteria in urine and find the best antibiotic in under 4 hours, thus enabling a rapid diagnosis and use of the most appropriate and cost-effective antimicrobial agent for the agent detected.
Detailed description
Testing done in this study will be performed either on bacterial isolates stored in the microbiology laboratory at the Diagnostic and Scientific Center in Calgary, or on up to one milliliter of residual urine sample submitted to the diagnostic laboratory with a request for urine culture and sensitivity. All urine cultures will be performed and reported in accordance with standards laboratory protocols. Research testing will only be done on residual sample once patient samples are processed or reported on for clinical purposes.
During the first phase of the study, metabolic biomarkers for uropathogens will be identified using mass spectrometry on sub-cultures of frozen isolates from the diagnostic microbiology laboratory. This will include at least 50 isolates each of uropathogens consisting of but not limited to Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterobacter species, Proteus mirabilis, Citrobacter species, Staphylococcus aureus, Staphylococcus saprophyticus, Pseudomonas aeruginosa, Enterococcus species, and Candida species. Biomarkers that are present in greater than 95% of the isolates will subsequently be using the analysis of 2000 negative, and 2000 positive urine cultures. Compounds that are subsequently identified as high yield will be selected for carbon 13 labeling to service standards.
In phase II of the study, following the development of a biomarker enrichment device at the CMRF, a performance urinalysis of the device will be conducted using residual urine sample from 1000 negative and 2000 positive urine specimens as outlined above. The performance of the new device will be evaluated relative to standard cultures and urine liquid chromatography-mass spectrometry.
Following the creation of a sensitive and specific assay, a prospective study will be carried out at the diagnostic microbiology laboratory. 3000 sample submitted for urine culture will be process in parallel with the new device and standard microbiology procedures. Sensitivity, specificity and predictive value for each analyte compared to standard culture will be determined in this portion of the study. Cost calculations and performance characteristics including turnaround time of the new assay will be compared to that in the standard laboratory procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UTI Positive | – | –In phase I of the study testing residual urine samples the aim is to include at least 50 positive samples from each bacterial species known to be commonly associated with urinary tract infections. We selected 2000 positive urines to enable capturing enough of these organisms in the development process. For phase II of the study, the same number of positive samples in order to include all common species causing urinary tract infection. The number of negative samples included is reduced to 1000. Phase 3 - approximately one third of all urine sample submitted will be positive for a uropathogen. Sample size of 3000 we expect 1000 these to be culture positive. We expect most uropathogens occurring at a frequency of 5% or more will be included with sufficient numbers in the validation process. |
| UTI Negative Control | – | –2000 negative urine samples are being run as controlled to ensure the false positivity rate is low. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The majority of urine samples collected in Calgary coming from young healthy females with symptoms of cystitis or pyelonephritis. However, residual sample from any patient where a urine culture has been ordered could be included in the study if it falls within the time during which residual samples are being processed.
Key inclusion criteria (1 listed)
- Patients who have not submitted urine samples will not be included as the samples are required for both standard testing and research. This would include patients who are being treated empirically by physicians.
Key exclusion criteria (1 listed)
- Patient's who have not submitted urine samples for culture will not be included in study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assay ID Validation
Time frame: 2 years
In the validation phase of the study sensitivity, specificity and positive and negative predictive values for detecting significant bacteriuria using culture as the gold standard, These values will be calculated for the whole cohort as per standard definitions using statistical software (Analyse-it for Excel).
2 secondary outcomes
Susceptibility - anti-microbial susceptibility of new assay versus standard laboratory methods
Time frame: 2 years
Turn-around-time to bacterial detection and susceptibility
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No. No data will be made available to other researchers
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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.
Ian A Lewis, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Urinary Tract Infection, run by University of Calgary at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian A Lewis, PhD (403-220-4366, ian.lewis2@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assay ID Validation (time frame: 2 years). 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 Jun 2022.