Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-ID Testing Menu (IDTM) and Standard Laboratory Culture

Bladder Cancer Clinical Trial

— VS-UrineID  

Official title:

Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-IDTM and Standard Laboratory Culture

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04583553
• Other study ID #: VS-UrineID
• Status: Not yet recruiting
• Start date: December 15, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2021
• Source: University of Kansas Medical Center
• Contact: Katie Glavin
• Phone: 9135888721
• Email: kglavin[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to provide informed consent.

2. Age = 18 years

3. Diagnosis of Non-Muscle Invasive Bladder Cancer (NMIBC)

4. Onset of cystitis or UTI symptoms within 7 days of Transurethral Resection of the Bladder Tumor (TURBT) or BCG installation

5. Ability to collect urine sample for analysis via standard laboratory culture and Vikor Scientific Urine-IDTM

Exclusion Criteria:

1. Inability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness provide informed consent

2. Age <18 years

3. Diagnosis of Muscle-Invasive or metastatic bladder cancer

4. Onset of cystitis greater than 7 days following TURBT or BCG installation

5. Inability to provide sufficient urine for both standard laboratory culture and Vikor Scientific Urine-IDTM

6. Current prophylactic antibiotic use.

Related Conditions & MeSH terms

• Bladder Cancer
• Cystitis
• Urinary Bladder Neoplasms
• Urinary Tract Infections

Intervention

Diagnostic Test:
• Vikor Scientific Urine-IDTM
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.

Locations

Country	Name	City	State
United States	University of Kansas Medcial Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Vikor Scientific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years
Primary	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.		2 years
Secondary	To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile		2 years
Secondary	To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism		2 years