Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)

Conditions
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Urinary Tract Infections, Prostatitis, Interstitial Cystitis

Intervention / Treatment
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* Diagnostic Test: Guidance 4.0 PCR test
* Diagnostic Test: Urine Culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patient Informed Consent form completed Male and Female Subjects may participate with no predetermined quotas or ratios for gender participation. All patients must be ≥60 years old. For patients presenting with a diagnosis of interstitial cystitis, patients may be of any age. Patients must be presenting for treatment of acute UTI, complicated UTI, persistent UTI, or recurrent UTI's. Including prostatitis, pyelonephritis, and/or interstitial cystitis. Data pertaining to the times at which the specimen samples are collected and stabilized needs to be documented. Specimen samples obtained need to have a sufficient volume necessary to perform a urine culture and Guidance 4.0. Exclusion Criteria: • Do not provide written informed Consent with HIPAA authorization form. Taking antibiotics for any reason other than UTI at the time of enrollment Patients with chronic (> 10 days) indwelling catheters Self-catheterized patients Patients with neobladders

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Culture Only<br>Physician receives only culture result | Diagnostic Test: Urine Culture<br>* 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.<br>|
| Active Comparator: Guidance 4.0 PCR test only<br>Physician receives Guidance report only | Diagnostic Test: Guidance 4.0 PCR test<br>* 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.<br>|
| Active Comparator: Culture and Guidance 4.0 PCR test Group<br>Physician receives both results, gets Culture report immediately before Guidance | Diagnostic Test: Guidance 4.0 PCR test<br>* 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.<br>Diagnostic Test: Urine Culture<br>* 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.<br>|
| Active Comparator: Guidance 4.0 PCR test and culture group<br>Physician receives both results, gets Guidance report immediately before culture | Diagnostic Test: Guidance 4.0 PCR test<br>* 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.<br>Diagnostic Test: Urine Culture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI, IC