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Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

Primary Purpose

Urinary Tract Infections-UTI

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
culture versus Molecular diagnostics
Sponsored by
Southwest Regional PCR, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections-UTI

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A-Culture and Sensitivity group

    B-Diagnosis by Molecular Testing

    Arm Description

    Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table

    Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Time from participant reported start of UTI symptoms to resolution.
    collect time of reported UTI from Subject
    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
    Overall cost
    collect data on the overall cost of Subject treatment

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    October 3, 2017
    Sponsor
    Southwest Regional PCR, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02623179
    Brief Title
    Conventional and Molecular Diagnostic Method for Patients With Suspected UTI
    Official Title
    Conventional and Molecular Diagnostic Method for Patients With Suspected Urinary Tract Infections: Clinical, Economic, and Quality of Life Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Southwest Regional PCR, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infections-UTI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A-Culture and Sensitivity group
    Arm Type
    Active Comparator
    Arm Description
    Diagnosis by Culture and Sensitivity group-Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table
    Arm Title
    B-Diagnosis by Molecular Testing
    Arm Type
    Active Comparator
    Arm Description
    Diagnosis by Molecular Testing-Treatment based on the results of the PathoGenius molecular testing - Even Numbers on randomization table
    Intervention Type
    Other
    Intervention Name(s)
    culture versus Molecular diagnostics
    Intervention Description
    Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table
    Primary Outcome Measure Information:
    Title
    To quantify differences in the relative abundance and presence of microbial lineages as determined by culture and sequencing technologies.
    Description
    comparison of culture and sensitivity results to the molecular results
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Time (as measured in hours) to preliminary and final identification of organism(s) and antibiotic sensitivity(s) results
    Description
    time from collection of sample to diagnostic result delivery
    Time Frame
    1 year
    Title
    Time from participant reported start of UTI symptoms to resolution.
    Description
    collect time of reported UTI from Subject
    Time Frame
    1 year
    Title
    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
    Description
    collect data from Subject as outlined in the Quality of Life Assessment
    Time Frame
    1 year
    Title
    Overall cost
    Description
    collect data on the overall cost of Subject treatment
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael McDonald, MD
    Organizational Affiliation
    Florida Hospital Celebration Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

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