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Completed

NCT Number: NCT05591911

Urine Gene Analysis for Pathogen Detection

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine PCR testing

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.

Primary outcomes

  1. Time in hours from patient presentation to optimal antibiotic prescription

    Time frame: Up to 30 days

    Time in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization.

Secondary outcomes

  1. Antibiotic costs as measured by prescription records

    Time frame: Up to 30 days

    Antibiotic costs spent for UTI treatment will be calculated.

  2. Number of patients with antibiotic change as measured by prescription records

    Time frame: Up to 30 days

    In cases where the UTI cannot be treated with the first antibiotic, other antibiotics used for this purpose will be recorded.

  3. Duration of antibiotic usage as measured by prescription records

    Time frame: Up to 30 days

    Antibiotic usage duration will be recorded.

  4. Number of any HCP visits for same issue as measured by patients reports/medical records

    Time frame: Up to 30 days

    Any visit to HCP for the same issue will be evaluated

  5. Number of hospitalization related to UTI as measured by patients reports/medical records

    Time frame: Up to 30 days

    Hospitalization related to UTI will be recorded.

  6. Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records

    Time frame: Up to 30 days

    Additional diagnostic procedures completed in relation to UTI will be recorded.

Sponsors and collaborators

Lead sponsor

David Sheyn

Other

Collaborators

  • Thermo Fisher Scientific, Inc
  • Vikor Scientific

Registry information

Official study title

Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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