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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic Patients with low Colony Count | Other | Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count <10,000 to be treated based on Next Generation Sequencing result. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic | Drug | FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC >0 and <10,000 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Majid Mirzazadeh, MD | Contact | 336-716-4310 | mmirzaza@wakehealth.edu | |
| Sachin N Vyas, MS, PhD | Contact | 336-713-4098 | sachin.vyas@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Majid Mirzazadeh, MD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
Individual Participant Data are not planned to be shared. All subject related information will be available under the subject ID.
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000667 | Ampicillin |
| D000658 | Amoxicillin |
| D005493 | Folic Acid Antagonists |
| D002511 | Cephalosporins |
| D002981 | Clindamycin |
| D024841 | Fluoroquinolones |
| D005578 | Fosfomycin |
| D000069349 | Linezolid |
| D008795 | Metronidazole |
| D009582 | Nitrofurantoin |
| D010406 | Penicillins |
| D013754 | Tetracyclines |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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.
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|
| Next Gen | Device | Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes. |
|
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010400 |
| Penicillin G |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D013843 | Thiazines |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D009581 | Nitrofurans |
| D005663 | Furans |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |