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| Name | Class |
|---|---|
| Comprehensive Urology-a Division of Michigan Healthcare Professionals | UNKNOWN |
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In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.
The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by the previous prospective comparison study. Additionally, conventional methods are often inadequate in the case of polymicrobial infections. More accurate and timely pathogen identification allows for prompt and more targeted treatment with less reliance on empiric therapy and decreased rates of antibiotic therapy changes and retreatment. This leads to more favorable patient outcomes and decreases the development of resistant organisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culture Only | Active Comparator | Physician receives only culture result |
|
| Guidance 4.0 PCR test only | Active Comparator | Physician receives Guidance report only |
|
| Culture and Guidance 4.0 PCR test Group | Active Comparator | Physician receives both results, gets Culture report immediately before Guidance |
|
| Guidance 4.0 PCR test and culture group | Active Comparator | Physician receives both results, gets Guidance report immediately before culture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidance 4.0 PCR test | Diagnostic Test | All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Establish Safety: composite adverse event rate | Demonstrate safety of Guidance 4.0 multiplex real-time PCR organism identification with mixed floral antibiotic resistance profiling guided treatment. Safety will be measured with a composite adverse event outcome of urosepsis, pyelonephritis, hospitalization, or the need to attend an urgent care center. The composite adverse event rate in the arm tested with Guidance 4.0 will be shown to be non-inferior to that in the arm tested with traditional urine culture. Superiority will also be tested. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Recurrent and Persistent Infections in Each Arm | Demonstrate non-inferiority and possibly superiority of Guidance 4.0 over traditional urine C&S with respect to the percentage of recurrent and persistent infections. Persistent is remaining infection at day 7 and recurrent infection is a person that had a second infection within 30 days that was treated with antibiotics. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Choice for Decision Making when Provided Both Results | • To determine which test physicians, rely upon when given the results of both traditional urine C&S vs. Guidance 4.0. | 4 Months |
Inclusion Criteria:
• Patient Informed Consent form completed
Exclusion Criteria:
• Do not provide written informed Consent with HIPAA authorization form.
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| Name | Affiliation | Role |
|---|---|---|
| Kirk Wojno, MD | Comprehensive Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Urology | Royal Oak | Michigan | 48037 | United States |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D011472 | Prostatitis |
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Urine Culture | Diagnostic Test | All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm. |
|
| Time to Symptom Resolution in Each Arm | Demonstrate superiority of Guidance 4.0 over traditional urine C&S with respect to the time to symptom resolution as demonstrated by UTISA tool. Symptom resolution will be defined as an overall rating of no symptoms on the UTISA questionnaire. | 7 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |