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

Not Applicable

Completed

• Conditions: Urinary Tract Infections; Prostatitis; Interstitial Cystitis
• Interventions: Diagnostic Test: Guidance 4.0 PCR test; Diagnostic Test: Urine Culture

• Registration Number: NCT03931538
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-07-17
• Primary Completion: 2019-02-22
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Study Completion: 2019-10-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2511

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Guidance 4.0 PCR test and culture group	Guidance 4.0 PCR test	Physician receives both results, gets Guidance report immediately before culture
Culture and Guidance 4.0 PCR test Group	Guidance 4.0 PCR test	Physician receives both results, gets Culture report immediately before Guidance
Culture and Guidance 4.0 PCR test Group	Urine Culture	Physician receives both results, gets Culture report immediately before Guidance
Guidance 4.0 PCR test and culture group	Urine Culture	Physician receives both results, gets Guidance report immediately before culture
Culture Only	Urine Culture	Physician receives only culture result
Guidance 4.0 PCR test only	Guidance 4.0 PCR test	Physician receives Guidance report only

Primary Outcome Measures

Name	Time	Method
Establish Safety: composite adverse event rate	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

Name	Time	Method
Time to Symptom Resolution in Each Arm	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.
Number of Patients with Recurrent and Persistent Infections in Each Arm	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.

Trial Locations

Locations (1)

Comprehensive Urology; 🇺🇸 Royal Oak, Michigan, United States