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

NCT03931538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2511

Last updated 2023-08-28

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Comprehensive Urology-a Division of Michigan Healthcare Professionals

    collaborator UNKNOWN

  • Pathnostics

    lead INDUSTRY

Principal Investigators

  • Kirk Wojno, MD · Comprehensive Urology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2019-02-22
Completion
2019-10-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931538 on ClinicalTrials.gov