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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931538
Recruitment Status : Active, not recruiting
First Posted : April 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Comprehensive Urology-a Division of Michigan Healthcare Professionals
Information provided by (Responsible Party):
Pathnostics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Prostatitis Interstitial Cystitis Diagnostic Test: Guidance 4.0 PCR test Diagnostic Test: Urine Culture Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : February 22, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Culture Only
Physician receives only culture result
Diagnostic Test: Urine Culture
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.

Active Comparator: Guidance 4.0 PCR test only
Physician receives Guidance report only
Diagnostic Test: Guidance 4.0 PCR 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.

Active Comparator: Culture and Guidance 4.0 PCR test Group
Physician receives both results, gets Culture report immediately before Guidance
Diagnostic Test: Guidance 4.0 PCR 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.

Diagnostic Test: Urine Culture
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.

Active Comparator: Guidance 4.0 PCR test and culture group
Physician receives both results, gets Guidance report immediately before culture
Diagnostic Test: Guidance 4.0 PCR 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.

Diagnostic Test: Urine Culture
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.




Primary Outcome Measures :
  1. Establish Safety: composite adverse event rate [ Time Frame: 7 Days ]
    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.


Secondary Outcome Measures :
  1. Number of Patients with Recurrent and Persistent Infections in Each Arm [ Time Frame: 7 Days ]
    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.

  2. Time to Symptom Resolution in Each Arm [ Time Frame: 7 days ]
    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.


Other Outcome Measures:
  1. Physician Choice for Decision Making when Provided Both Results [ Time Frame: 4 Months ]
    • To determine which test physicians, rely upon when given the results of both traditional urine C&S vs. Guidance 4.0.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931538


Locations
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United States, Michigan
Comprehensive Urology
Royal Oak, Michigan, United States, 48037
Sponsors and Collaborators
Pathnostics
Comprehensive Urology-a Division of Michigan Healthcare Professionals

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Responsible Party: Pathnostics
ClinicalTrials.gov Identifier: NCT03931538     History of Changes
Other Study ID Numbers: Pathnostics RapID MixAR
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pathnostics:
UTI
IC
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Infection
Urinary Tract Infections
Cystitis
Cystitis, Interstitial
Prostatitis
Urologic Diseases
Urinary Bladder Diseases
Prostatic Diseases
Genital Diseases, Male