NextGen - Clinical Implication of Next Generation Sequencing

Study Overview
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Brief Summary
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Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.

Detailed Description
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Bacterial sensitivity test for different antibiotics are the most important guide for treatment of patients with UTI. Unfortunately, for patients with less than 10,000 Colony Count (CC), usually no sensitivity test is done and there is not any guide for appropriate antibiotic therapy for this group.

Official Title
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Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Antibiotic
* Device: Next Gen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 to 80 years of age U/C (Urinary Culture) growth of <10,000 Colony-Forming Units (CFU) Understanding and acceptance of the need to return for all scheduled follow-up visits Able to give informed consent Exclusion Criteria: Catheter in use (Foley or suprapubic or intermittent) Not able to provide clean midstream urine Antibiotic consumption in the past 2 weeks before signing the consent Pregnant or Planning to Conceive Incarcerated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with Urinary Tract Infection (UTI) symptoms and Colony-forming Units (CFU) <10,000 have clinically significant UTIs. Characterizing the species of bacteria growing in low numbers and treating the patients based on bacterial sensitivity will help in resolving patients' symptoms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Symptomatic Patients with low Colony Count<br>Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result. | Drug: Antibiotic<br>* FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000<br>* Other names: Tetracyclines;Device: Next Gen<br>* Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) | NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000. Result Measure: NGS CC 100 to 10,000 | Baseline | 
| Next Generation Sequencing (NGS) Results (numbers of colony count (CC)) of Urinary Tract Infection (UTI) | NGS Ability to Detect Bacteria among patients with UTI Colony Count (CC) of Bacteria <10,000, Result Measure: NGS CC 100 to 10,000 | 3 Weeks Post-Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 | NGS result focused antibiotic treatment and symptom outcome with the measurement of King's Questionnaire Outcome. Result Measure: Mild, Moderate, and Severe UTI symptoms in last 12 and 24 hours on 7 questions with no symptoms as 0, Mild as 1, Moderate as 2, and Severe as 3 | Baseline | 
| Patient Improvement (King's Questionnaire Outcome measure) in UTI symptoms with CC <10,000 | NGS result focused antibiotic treatment and symptom outcome with the measurement of King's Questionnaire Outcome. Result Measure: Mild, Moderate, and Severe UTI symptoms in last 12 and 24 hours on 7 questions with no symptoms as 0, Mild as 1, Moderate as 2, and Severe as 3 | 3 Weeks Post-Treatment |