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

Urinary Tract Infections Clinical Trial

— RapIDMixAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931538
• Other study ID #: Pathnostics RapID MixAR
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2023
• Source: Pathnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2511
• Est. completion date: October 1, 2019
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Infections
• Interstitial Cystitis
• Prostatitis
• Urinary Tract Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Comprehensive Urology	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Pathnostics	Comprehensive Urology-a Division of Michigan Healthcare Professionals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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