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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03931538

Recruitment Status Active, not recruiting

First Posted April 30, 2019

Last update posted September 30, 2019

Study Description

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:Urinary Tract Infections
    Prostatitis
    Interstitial Cystitis
  • Intervention/Treatment: Diagnostic Test: Guidance 4.0 PCR test
    Diagnostic Test: Urine Culture
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2018
  • Estimated Primary Completion Date: February 2019
  • Actual Study Completion Date: October 2019
Arms and interventions
Arm Intervention/treatment
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.
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 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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

United States, Michigan
Comprehensive Urology
Royal Oak

Sponsors and Collaborators

Pathnostics

Comprehensive Urology-a Division of Michigan Healthcare Professionals

More Information
  • 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
  • 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.: Yes
  • Keywords provided by Pathnostics: IC UTI
  • Additional relevant MeSH terms: Infection
    Urinary Tract Infections
    Cystitis
    Cystitis, Interstitial
    Prostatitis