Urinary Tract InfectionsVS-UrineIDNCT04583553
Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-ID Testing Menu (IDTM) and Standard Laboratory Culture
An observational study of Urinary Tract Infections and Bladder Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Vikor Scientific Urine-IDTM is a molecular analysis technology which provides pathogen detection, quantification, and resistance gene identification. Urine-IDTM delivers its results through the technology platform Antibiotic Stewardship program (ABXAssist™), which provides results incorporating regional sensitivity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Bladder Cancer
- What is being tested?
- Vikor Scientific Urine-IDTM
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 30 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study participants will be enrolled from KUMC hospital and clinics. A total of 175 participants will be recruited. Participants undergoing the study will be asked to submit urine sample to KUMC Lab within 7 days of onset on cystitis symptoms. Urine sample will be divided for use in standard laboratory culture and Vikor Scientific Urine-IDTM. Urine-IDTM samples will be collected with kits provide by Vikor Scientific. Urine-IDTM kits will be expedited to Vikor Scientific Lab immediately following collection.
Who may be able to join
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to provide informed consent.
- Age ≥ 18 years
- Diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC)
- Onset of cystitis or UTI symptoms within 7 days of Transurethral Resection of the Bladder Tumor (TURBT) or BCG installation
- Ability to collect urine sample for analysis via standard laboratory culture and Vikor Scientific Urine-IDTM
Who cannot join
- Inability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness provide informed consent
- Age <18 years
- Diagnosis of Muscle-Invasive or metastatic bladder cancer
- Onset of cystitis greater than 7 days following TURBT or BCG installation
- Inability to provide sufficient urine for both standard laboratory culture and Vikor Scientific Urine-IDTM
- Current prophylactic antibiotic use.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medcial Center
Kansas City, Kansas, 66160
About this study
Official title: Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-IDTM and Standard Laboratory Culture
Vikor Scientific Urine-IDTM is a molecular analysis technology which provides pathogen detection, quantification, and resistance gene identification. Urine-IDTM delivers its results through the technology platform Antibiotic Stewardship program (ABXAssist™), which provides results incorporating regional sensitivity and susceptibility patterns, medication costs, antibiotic spectrum of activity, and FDA guidance. This product aims to deliver prompt, patient-centered and value-based guidance to clinicians for antibiotic selection within 24 hours of delivery to testing facility.
Proposed advantages of Vikor Scientific Urine-IDTM include:
Read more
- Expeditious result (within 24 hours post-lab arrival)
- Simultaneous detection of polymicrobial and monomicrobial infections
- Identification of 49 most common antibiotic resistance genes
- Provision of up-to-date regional sensitivity and susceptibility patterns
- Provision of cost-sensitive treatment options and FDA guidance
- Easy accessibility (mobile, web-portal and electronic health records Integration)
This utility of this technology has yet to be investigated in a clinical study and could prove to be a viable alternative or adjunctive diagnostic tool to standard laboratory culture. Standard laboratory culture can take up to 7 days to return pathogen identification and antibiotic susceptibility, potentially delaying appropriate care and prolonging exposure to inappropriate empiric antibiotics. Our study aims to analyze the ability Vikor Scientific Urine-IDTM to improve time to identification of correct pathogen and accuracy of pathogen identification when compared to standard laboratory culture.
Read the detailed description
Commercially available Vikor Scientific Urine-IDTM urine collection kits will be provided to the University of Kansas Medical Center (KUMC) Department of Urology by Vikor Scientific.
Urine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab.
Provider clinical decision making will be based on standard laboratory cultures and therapy will not be adjusted based on Vikor Urine-IDTM results.
- Conditions
- Urinary Tract Infections, Bladder Cancer
- Being tested
- Vikor Scientific Urine-IDTM
- Medical subject headings
- Urinary Tract Infections, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vikor Scientific Urine-IDTMDiagnostic test
Urine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Vikor Scientific Urine-IDTM can identify pathogen (or absence thereof) causing post-TURBT or post-bacillus Calmette Guerin (BCG) cystitis in a timelier manner than standard laboratory culture.
Measured: 2 years
To determine if Vikor Scientific Urine-IDTM provides concordant identification or urinary pathogen and antimicrobial sensitivity compared to standard laboratory culture in post-TURBT or post-BCG cystitis.
Measured: 2 years
Secondary outcomes (2)
To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile
Measured: 2 years
To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism
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 posted12 Oct 2020
- Study start15 Dec 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: Site did not proceed with study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vikor Scientific
- Responsible party
- Principal investigator, Eugene Lee, MD, University of Kansas Medical Center
- Investigators
- Eugene Lee, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583553
- Sponsor's protocol ID
- VS-UrineID
- Acronym
- VS-UrineID
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed at KUMC and published
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-IDTM and Standard Laboratory Culture
- ClinicalTrials.gov ID
- NCT04583553
- Acronym / sponsor ID
- VS-UrineID / VS-UrineID
- Conditions
- Urinary Tract Infections, Bladder Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Site did not proceed with study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Vikor Scientific
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Oct 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.
Vikor Scientific Urine-IDTM is a molecular analysis technology which provides pathogen detection, quantification, and resistance gene identification. Urine-IDTM delivers its results through the technology platform Antibiotic Stewardship program (ABXAssist™), which provides results incorporating regional sensitivity and susceptibility patterns, medication costs, antibiotic spectrum of activity, and FDA guidance. This product aims to deliver prompt, patient-centered and value-based guidance to clinicians for antibiotic selection within 24 hours of delivery to testing facility.
Proposed advantages of Vikor Scientific Urine-IDTM include:
- Expeditious result (within 24 hours post-lab arrival)
- Simultaneous detection of polymicrobial and monomicrobial infections
- Identification of 49 most common antibiotic resistance genes
- Provision of up-to-date regional sensitivity and susceptibility patterns
- Provision of cost-sensitive treatment options and FDA guidance
- Easy accessibility (mobile, web-portal and electronic health records Integration)
This utility of this technology has yet to be investigated in a clinical study and could prove to be a viable alternative or adjunctive diagnostic tool to standard laboratory culture. Standard laboratory culture can take up to 7 days to return pathogen identification and antibiotic susceptibility, potentially delaying appropriate care and prolonging exposure to inappropriate empiric antibiotics. Our study aims to analyze the ability Vikor Scientific Urine-IDTM to improve time to identification of correct pathogen and accuracy of pathogen identification when compared to standard laboratory culture.
Detailed description
Commercially available Vikor Scientific Urine-IDTM urine collection kits will be provided to the University of Kansas Medical Center (KUMC) Department of Urology by Vikor Scientific.
Urine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab.
Provider clinical decision making will be based on standard laboratory cultures and therapy will not be adjusted based on Vikor Urine-IDTM results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants will be enrolled from KUMC hospital and clinics. A total of 175 participants will be recruited. Participants undergoing the study will be asked to submit urine sample to KUMC Lab within 7 days of onset on cystitis symptoms. Urine sample will be divided for use in standard laboratory culture and Vikor Scientific Urine-IDTM. Urine-IDTM samples will be collected with kits provide by Vikor Scientific. Urine-IDTM kits will be expedited to Vikor Scientific Lab immediately following collection.
Key inclusion criteria (5 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to provide informed consent.
- Age ≥ 18 years
- Diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC)
- Onset of cystitis or UTI symptoms within 7 days of Transurethral Resection of the Bladder Tumor (TURBT) or BCG installation
- Ability to collect urine sample for analysis via standard laboratory culture and Vikor Scientific Urine-IDTM
Key exclusion criteria (6 listed)
- Inability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness provide informed consent
- Age <18 years
- Diagnosis of Muscle-Invasive or metastatic bladder cancer
- Onset of cystitis greater than 7 days following TURBT or BCG installation
- Inability to provide sufficient urine for both standard laboratory culture and Vikor Scientific Urine-IDTM
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 |
|---|---|---|
| Vikor Scientific Urine-IDTMUrine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab. | Diagnostic test | – |
Primary outcome
To determine if Vikor Scientific Urine-IDTM can identify pathogen (or absence thereof) causing post-TURBT or post-bacillus Calmette Guerin (BCG) cystitis in a timelier manner than standard laboratory culture.
Time frame: 2 years
To determine if Vikor Scientific Urine-IDTM provides concordant identification or urinary pathogen and antimicrobial sensitivity compared to standard laboratory culture in post-TURBT or post-BCG cystitis.
Time frame: 2 years
2 secondary outcomes
To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile
Time frame: 2 years
To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. Data will be analyzed at KUMC and published
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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.
Eugene Lee, MD principal investigator
University of Kansas Medical Center
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 Urinary Tract Infections and Bladder Cancer, run by University of Kansas Medical Center at 1 site in United States.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 15 Oct 2024. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine if Vikor Scientific Urine-IDTM can identify pathogen (or absence thereof) causing post-TURBT or post-bacillus Calmette Guerin (BCG) cystitis in a timelier manner than standard laboratory culture. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 15 Oct 2024.