Urinary Tract InfectionsNCT05591911
Urine Gene Analysis for Pathogen Detection
An observational study of Urinary Tract Infections, run by David Sheyn at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Urine PCR testing
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female and male patients over 60 years old who admit with acute urinary tract infection symptoms to the ambulatory clinics will be included in this research.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis
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.
- Conditions
- Urinary Tract Infections
- Being tested
- Urine PCR testing
- Keywords
- Urinary tract infection, Urine culture, Bacteriel growth, Antibiotics, PCR
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine PCR testingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients over 60 years old presenting with acute urinary tract infection symptoms | Not described Receives: Diagnostic Test: Urine PCR testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in hours from patient presentation to optimal antibiotic prescription
Time in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization.
Measured: Up to 30 days
Secondary outcomes (6)
Antibiotic costs as measured by prescription records
Antibiotic costs spent for UTI treatment will be calculated.
Measured: Up to 30 days
Number of patients with antibiotic change as measured by prescription records
In cases where the UTI cannot be treated with the first antibiotic, other antibiotics used for this purpose will be recorded.
Measured: Up to 30 days
Duration of antibiotic usage as measured by prescription records
Antibiotic usage duration will be recorded.
Measured: Up to 30 days
Number of any HCP visits for same issue as measured by patients reports/medical records
Any visit to HCP for the same issue will be evaluated
Measured: Up to 30 days
Number of hospitalization related to UTI as measured by patients reports/medical records
Hospitalization related to UTI will be recorded.
Measured: Up to 30 days
Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records
Additional diagnostic procedures completed in relation to UTI will be recorded.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start25 Jun 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Sheyn
- Sponsor type
- University, hospital or other
- Collaborators
- Vikor Scientific, Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor-investigator, David Sheyn, University Hospitals Cleveland Medical Center
- Investigators
- David Sheyn, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591911
- Sponsor's protocol ID
- STUDY20220767
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer HH, Jarvis MA, Hoffberg EA, Batur AF, Hojat LS, Hijaz AK, Sheyn D. Multiplex Polymerase Chain Reaction vs Standard Urine Culture in Women Presenting with Symptoms of Acute Cystitis. Int Urogynecol J. 2025 Dec;36(12):2517-2526. doi: 10.1007/s00192-025-06295-8. Epub 2025 Sep 5.
PubMed 40911199
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis
- ClinicalTrials.gov ID
- NCT05591911
- Acronym / sponsor ID
- STUDY20220767
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary tract infection, Urine culture, Bacteriel growth, Antibiotics, PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- David SheynUniversity, hospital or other
- Collaborators
- Vikor Scientific, Thermo Fisher Scientific, Inc
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients over 60 years old presenting with acute urinary tract infection symptoms | – | Diagnostic Test: Urine PCR testing |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male patients over 60 years old who admit with acute urinary tract infection symptoms to the ambulatory clinics will be included in this research.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine PCR testingThe urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms. | Diagnostic test | Patients over 60 years old presenting with acute urinary tract infection symptoms |
Primary outcome
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.
6 secondary outcomes
Antibiotic costs as measured by prescription records
Time frame: Up to 30 days
Number of patients with antibiotic change as measured by prescription records
Time frame: Up to 30 days
Duration of antibiotic usage as measured by prescription records
Time frame: Up to 30 days
Number of any HCP visits for same issue as measured by patients reports/medical records
Time frame: Up to 30 days
Number of hospitalization related to UTI as measured by patients reports/medical records
Time frame: Up to 30 days
Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 40911199Bauer HH, Jarvis MA, Hoffberg EA, Batur AF, Hojat LS, Hijaz AK, Sheyn D. Multiplex Polymerase Chain Reaction vs Standard Urine Culture in Women Presenting with Symptoms of Acute Cystitis. Int Urogynecol J. 2025 Dec;36(12):2517-2526. doi: 10.1007/s00192-025-06295-8. Epub 2025 Sep 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Sheyn, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by David Sheyn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in hours from patient presentation to optimal antibiotic prescription (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.