Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes

In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C & S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections-UTI
• Intervention / Treatment: Other: culture versus Molecular diagnostics

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Age greater than or equal to 18 and less than or equal to 89 years.

  • The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
  • Able to provide at least 8 ml urine total (urine for 2 pathology tests).
  • Is willing to complete one follow up surveys and send back to FH.

Exclusion Criteria:

• • Unable or unwilling to provide written informed consent.

  • Unable to read and write English (surveys are not available or validated in any other language than English).
  • Currently on any antibiotic for any clinical indication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A-Culture and Sensitivity group; Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table	Other: culture versus Molecular diagnostics; Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table
Active Comparator: B-Diagnosis by Molecular Testing; Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table	Other: culture versus Molecular diagnostics; Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.	comparison of culture and sensitivity results to the molecular results	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results	time from collection of sample to diagnostic result delivery	1 year
Time from participant reported start of UTI symptoms to resolution.	collect time of reported UTI from Subject	1 year
Participant Quality of Life as measured by a UTI specific severity and bothersome of symptoms survey taken at baseline (at clinic visit) and at set time points post urine testing	collect data from Subject as outlined in the Quality of Life Assessment	1 year
Overall cost	collect data on the overall cost of Subject treatment	1 year

Collaborators and Investigators

• Sponsor: Southwest Regional PCR, LLC
• Investigators: Principal Investigator: Michael McDonald, MD, Florida Hospital Celebration Health

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections
• Other Study ID Numbers: PATUTI

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