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Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

NCT ID: NCT02623179

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-15

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Urinary Tract Infections-UTI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

culture versus Molecular diagnostics

Intervention Type OTHER

Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table

B-Diagnosis by Molecular Testing

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

Group Type ACTIVE_COMPARATOR

culture versus Molecular diagnostics

Intervention Type OTHER

Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table

Interventions

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culture versus Molecular diagnostics

Treatment based on the results of the FH C \& S testing - Odd Numbers on randomization table

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Regional PCR, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael McDonald, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Celebration Health

Other Identifiers

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PATUTI

Identifier Type: -

Identifier Source: org_study_id