Urine Gene Analysis for Pathogen Detection

NCT ID: NCT05591911

Last Updated: 2024-10-24

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

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-25

Study Completion Date

2024-08-31

Brief Summary

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The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients over 60 years old presenting with acute urinary tract infection symptoms

Urine PCR testing

Intervention Type DIAGNOSTIC_TEST

The urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms.

Interventions

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Urine PCR testing

The urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult men and women 60 years and older who have urinary tract infection
* Can participate in the informed consent process
* Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days
* Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR
* Understand and are willing to comply with the study requirements.
* Sample collection able to be sent out the same day via courier

Exclusion Criteria

* Individuals under 60 years of age
* Unable to provide informed consent
* Urinary diversion of any type
* Chronic indwelling urinary catheter
* No recent history of UTI within the past 21 days
* No antibiotic therapy within the past 21 days
* No recent therapy with Phenazopyridine
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vikor Scientific

UNKNOWN

Sponsor Role collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role collaborator

David Sheyn

OTHER

Sponsor Role lead

Responsible Party

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David Sheyn

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Sheyn, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY20220767

Identifier Type: -

Identifier Source: org_study_id

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