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Urine Gene Analysis for Pathogen Detection

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05591911
Enrollment
96
Registered
2022-10-24
Start date
2023-06-25
Completion date
2024-08-31
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Urinary tract infection, Urine culture, Bacteriel growth, Antibiotics, PCR

Brief summary

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.

Interventions

DIAGNOSTIC_TESTUrine 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.

Sponsors

Vikor Scientific
CollaboratorUNKNOWN
Thermo Fisher Scientific, Inc
CollaboratorINDUSTRY
David Sheyn
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time in hours from patient presentation to optimal antibiotic prescriptionUp to 30 daysTime in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization.

Secondary

MeasureTime frameDescription
Number of patients with antibiotic change as measured by prescription recordsUp to 30 daysIn cases where the UTI cannot be treated with the first antibiotic, other antibiotics used for this purpose will be recorded.
Duration of antibiotic usage as measured by prescription recordsUp to 30 daysAntibiotic usage duration will be recorded.
Antibiotic costs as measured by prescription recordsUp to 30 daysAntibiotic costs spent for UTI treatment will be calculated.
Number of hospitalization related to UTI as measured by patients reports/medical recordsUp to 30 daysHospitalization related to UTI will be recorded.
Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical recordsUp to 30 daysAdditional diagnostic procedures completed in relation to UTI will be recorded.
Number of any HCP visits for same issue as measured by patients reports/medical recordsUp to 30 daysAny visit to HCP for the same issue will be evaluated

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026