Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNA Polymerase Chain Reaction (PCR) | Experimental | Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms. |
|
| Urine Culture | Active Comparator | Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA PCR | Device | Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms as measured by UTI-SIQ-8 questionnaire | The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe. | Baseline, one day after antibiotic completion |
| Change in symptoms as measured by the UTI Symptom Assessment questionnaire | The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms. | Baseline, one day after antibiotic completion |
| Measure | Description | Time Frame |
|---|---|---|
| Length of time from patient presentation to initiation of treatment as measured by medical record review | Up to 21 days | |
| Number of antibiotic changes as measured by medical record review | Up to 21 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana N Mitchell, MD, MBA, BSN | Contact | 216-844-1000 | diana.mitchell@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| David Sheyn, MD | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals | Recruiting | Cleveland | Ohio | 44106 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D019105 | Random Amplified Polymorphic DNA Technique |
| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Urine Culture | Diagnostic Test | Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture. |
|
| Duration of antibiotic use as measured by medical record review | Duration will be measured in days | Up to 21 days |
| Number of times participant represents with UTI symptoms as measured by medical record review | Duration will be measured in days | Up to 30 days |
| Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review | Up to 21 days |
| Number of hospitalizations related to UTI as measured by medical record review | Up to 21 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D015336 | Molecular Probe Techniques |