Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.
研究概览
简要总结
In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C & S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age greater than or equal to 18 and less than or equal to 89 years.
- •The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
- •Able to provide at least 8 ml urine total (urine for 2 pathology tests).
- •Is willing to complete one follow up surveys and send back to FH.
排除标准
- •• Unable or unwilling to provide written informed consent.
- •Unable to read and write English (surveys are not available or validated in any other language than English).
- •Currently on any antibiotic for any clinical indication.
研究组 & 干预措施
A-Culture and Sensitivity group
Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table
干预措施: culture versus Molecular diagnostics (Other)
B-Diagnosis by Molecular Testing
Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table
干预措施: culture versus Molecular diagnostics (Other)
结局指标
主要结局
To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.
时间窗: 1 year
comparison of culture and sensitivity results to the molecular results
次要结局
- Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results(1 year)
- Time from participant reported start of UTI symptoms to resolution.(1 year)
- Overall cost(1 year)
- Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing(1 year)