Clinical trial NCT03931538: Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study
Official title: Urinary Tract Infection: RapID Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Prostatitis
Interstitial Cystitis
Keywords: UTI
IC
Lead sponsor: Pathnostics
Sponsor class: INDUSTRY
Collaborators: name: Comprehensive Urology-a Division of Michigan Healthcare Professionals
First posted: 2019-04-30
Enrollment: 2511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Establish Safety: composite adverse event rate
timeFrame: 7 Days
Secondary outcomes:
measure: Number of Patients with Recurrent and Persistent Infections in Each Arm
timeFrame: 7 Days
measure: Time to Symptom Resolution in Each Arm
timeFrame: 7 days
Other outcomes:
measure: Physician Choice for Decision Making when Provided Both Results
timeFrame: 4 Months
Locations:
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
Study officials:
affiliation: Comprehensive Urology
name: Kirk Wojno, MD
role: PRINCIPAL_INVESTIGATOR
References: