Clinical trial NCT04583553: Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-ID Testing Menu (IDTM) and Standard Laboratory Culture
Official title: Comparative Microbial Analysis of Cystitis in Non-muscle-invasive Bladder Cancer Patients Using Vikor Scientific Urine-IDTM and Standard Laboratory Culture
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urinary Tract Infections
Bladder Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Vikor Scientific
First posted: 2020-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile
timeFrame: 2 years
measure: To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism
timeFrame: 2 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medcial Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Eugene Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: