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

Primary Purpose

Urinary Tract Infections, Prostatitis, Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guidance 4.0 PCR test
Urine Culture
Sponsored by
Pathnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections focused on measuring UTI, IC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Urology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Culture Only

Guidance 4.0 PCR test only

Culture and Guidance 4.0 PCR test Group

Guidance 4.0 PCR test and culture group

Arm Description

Physician receives only culture result

Physician receives Guidance report only

Physician receives both results, gets Culture report immediately before Guidance

Physician receives both results, gets Guidance report immediately before culture

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 25, 2019
Last Updated
August 24, 2023
Sponsor
Pathnostics
Collaborators
Comprehensive Urology-a Division of Michigan Healthcare Professionals
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1. Study Identification

Unique Protocol Identification Number
NCT03931538
Brief Title
Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study
Acronym
RapIDMixAR
Official Title
Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pathnostics
Collaborators
Comprehensive Urology-a Division of Michigan Healthcare Professionals

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Prostatitis, Interstitial Cystitis
Keywords
UTI, IC

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
2511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culture Only
Arm Type
Active Comparator
Arm Description
Physician receives only culture result
Arm Title
Guidance 4.0 PCR test only
Arm Type
Active Comparator
Arm Description
Physician receives Guidance report only
Arm Title
Culture and Guidance 4.0 PCR test Group
Arm Type
Active Comparator
Arm Description
Physician receives both results, gets Culture report immediately before Guidance
Arm Title
Guidance 4.0 PCR test and culture group
Arm Type
Active Comparator
Arm Description
Physician receives both results, gets Guidance report immediately before culture
Intervention Type
Diagnostic Test
Intervention Name(s)
Guidance 4.0 PCR test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine Culture
Intervention Description
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 Measure Information:
Title
Establish Safety: composite adverse event rate
Description
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.
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
Number of Patients with Recurrent and Persistent Infections in Each Arm
Description
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.
Time Frame
7 Days
Title
Time to Symptom Resolution in Each Arm
Description
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.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Physician Choice for Decision Making when Provided Both Results
Description
• To determine which test physicians, rely upon when given the results of both traditional urine C&S vs. Guidance 4.0.
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk Wojno, MD
Organizational Affiliation
Comprehensive Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Urology
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48037
Country
United States

12. IPD Sharing Statement

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

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