Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

Study Overview
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Brief Summary
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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.

Official Title
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Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes

Conditions
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Urinary Tract Infections-UTI

Intervention / Treatment
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* Other: culture versus Molecular diagnostics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A-Culture and Sensitivity group<br>Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table | Other: culture versus Molecular diagnostics<br>* Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table<br>|
| Active Comparator: B-Diagnosis by Molecular Testing<br>Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table | Other: culture versus Molecular diagnostics<br>* Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies. | comparison of culture and sensitivity results to the molecular results | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results | time from collection of sample to diagnostic result delivery | 1 year | 
| Time from participant reported start of UTI symptoms to resolution. | collect time of reported UTI from Subject | 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 | collect data from Subject as outlined in the Quality of Life Assessment | 1 year | 
| Overall cost | collect data on the overall cost of Subject treatment | 1 year |