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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Interstitial Cystitis; Prostatitis
• Intervention / Treatment: Diagnostic test: Urine Culture; Diagnostic test: Guidance 4.0 PCR test

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 Type: Interventional
• Enrollment (Actual): 2511
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48037
      • Comprehensive Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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: 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.; 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: Guidance 4.0 PCR test and culture group; Physician receives both results, gets Guidance report immediately before culture	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.; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pathnostics
• Collaborators: Comprehensive Urology-a Division of Michigan Healthcare Professionals
• Investigators: Principal Investigator: Kirk Wojno, MD, Comprehensive Urology

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): February 22, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: UTI; IC
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Prostatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Cystitis; Infections; Urinary Tract Infections; Cystitis, Interstitial; Prostatitis
• Other Study ID Numbers: Pathnostics RapID MixAR

Drug and device information, study documents

• 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