Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

Not Applicable

Completed

• Conditions: Urinary Tract Infections-UTI
• Interventions: Other: culture versus Molecular diagnostics

• Registration Number: NCT02623179
• Lead Sponsor: Southwest Regional PCR, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-07
• Study Start: 2016-01-15
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-Culture and Sensitivity group	culture versus Molecular diagnostics	Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table
B-Diagnosis by Molecular Testing	culture versus Molecular diagnostics	Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results	1 year	time from collection of sample to diagnostic result delivery
Time from participant reported start of UTI symptoms to resolution.	1 year	collect time of reported UTI from Subject
Overall cost	1 year	collect data on the overall cost of Subject treatment
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	1 year	collect data from Subject as outlined in the Quality of Life Assessment