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

University of Kansas

Status: Withdrawn

Conditions: Urinary Tract Infections; Bladder Cancer

Treatments: Diagnostic Test: Vikor Scientific Urine-IDTM

Study type: Observational

Funder types: Other

Identifiers

NCT04583553

VS-UrineID

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.