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临床试验/NCT04583553
NCT04583553撤回不适用

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

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
175
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: 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.

时间窗: 2 years

次要结局

  • 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(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eugene Lee, MD

Associate Professor

University of Kansas Medical Center

研究点 (1)

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