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| Name | Class |
|---|---|
| Vikor Scientific | UNKNOWN |
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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 (ABXAssistâ„¢), 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:
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vikor Scientific Urine-IDTM | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pathogens involved in post-TURBT and post-BCG Urinary Tract Infection (UTI) and their antibiotic susceptibility/resistance profile | 2 years | |
| To determine the prevalence of post-TURBT and post-BCG cystitis with no causative pathogenic organism |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Lee, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medcial Center | Kansas City | Kansas | 66160 | United States |
Data will be analyzed at KUMC and published
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Urine Samples will be collected for study
| 2 years |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001745 | Urinary Bladder Diseases |
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