Urine Gene Analysis for Pathogen Detection

Study Overview
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Brief Summary
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The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.

Official Title
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Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Diagnostic Test: Urine PCR testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women 60 years and older who have urinary tract infection Can participate in the informed consent process Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR Understand and are willing to comply with the study requirements. Sample collection able to be sent out the same day via courier Exclusion Criteria: Individuals under 60 years of age Unable to provide informed consent Urinary diversion of any type Chronic indwelling urinary catheter No recent history of UTI within the past 21 days No antibiotic therapy within the past 21 days No recent therapy with Phenazopyridine

Ages Eligible for Study
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Minimum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients over 60 years old presenting with acute urinary tract infection symptoms<br> | Diagnostic Test: Urine PCR testing<br>* The urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in hours from patient presentation to optimal antibiotic prescription | Time in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization. | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic costs as measured by prescription records | Antibiotic costs spent for UTI treatment will be calculated. | Up to 30 days | 
| Number of patients with antibiotic change as measured by prescription records | In cases where the UTI cannot be treated with the first antibiotic, other antibiotics used for this purpose will be recorded. | Up to 30 days | 
| Duration of antibiotic usage as measured by prescription records | Antibiotic usage duration will be recorded. | Up to 30 days | 
| Number of any HCP visits for same issue as measured by patients reports/medical records | Any visit to HCP for the same issue will be evaluated | Up to 30 days | 
| Number of hospitalization related to UTI as measured by patients reports/medical records | Hospitalization related to UTI will be recorded. | Up to 30 days | 
| Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records | Additional diagnostic procedures completed in relation to UTI will be recorded. | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary tract infection, Urine culture, Bacteriel growth, Antibiotics, PCR