Urinary Tract InfectionsNCT06808451
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
A study testing DNA PCR and Urine Culture in people with Urinary Tract Infections, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- DNA PCR and Urine Culture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women 18 years and older
- Presenting to clinic with symptoms of UTI or cystitis
- Patients with Medicare and Medicaid insurance
Who cannot join
- Urinary diversion of any type
- Chronic indwelling urinary catheter
- Diagnosed UTI within the previous 21 days
- Antibiotic therapy within the previous 21 days
- Use of phenazopyridine within the previous 21 days
- Commercial insurance
- Non-English speaking
- Pregnant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Diana N Mitchell, MD, MBA, BSN, 216-844-1000, diana.mitchell@uhhospitals.org
About this study
Official title: Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.
- Conditions
- Urinary Tract Infections
- Being tested
- DNA PCR, Urine Culture
- Keywords
- urine culture, DNA 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.
DNA PCRDevice
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Urine CultureDiagnostic test
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
| Study group | Role | What they receive |
|---|---|---|
| DNA Polymerase Chain Reaction (PCR) | Experimental | Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms. Receives: Device: DNA PCR |
| Urine Culture | Active comparator | Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture. Receives: Diagnostic Test: Urine Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms as measured by UTI-SIQ-8 questionnaire
The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.
Measured: Baseline, one day after antibiotic completion
Change in symptoms as measured by the UTI Symptom Assessment questionnaire
The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.
Measured: Baseline, one day after antibiotic completion
Secondary outcomes (6)
Length of time from patient presentation to initiation of treatment as measured by medical record review
Measured: Up to 21 days
Number of antibiotic changes as measured by medical record review
Measured: Up to 21 days
Duration of antibiotic use as measured by medical record review
Duration will be measured in days
Measured: Up to 21 days
Number of times participant represents with UTI symptoms as measured by medical record review
Duration will be measured in days
Measured: Up to 30 days
Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review
Measured: Up to 21 days
Number of hospitalizations related to UTI as measured by medical record review
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start22 Oct 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sheyn, University Hospitals Cleveland Medical Center
- Investigators
- David Sheyn, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808451
- Sponsor's protocol ID
- STUDY20241345
- Status last verified
- Nov 2026
- First submitted
- 29 Jan 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06808451
- Acronym / sponsor ID
- STUDY20241345
- Conditions
- Urinary Tract Infections
- Keywords
- urine culture, DNA PCR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 5 Feb 2025 (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.
Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNA Polymerase Chain Reaction (PCR) | Experimental | Device: DNA PCRGene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms. |
| Urine Culture | Active comparator | Diagnostic Test: Urine CultureUrine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men and women 18 years and older
- Presenting to clinic with symptoms of UTI or cystitis
- Patients with Medicare and Medicaid insurance
Key exclusion criteria (8 listed)
- Urinary diversion of any type
- Chronic indwelling urinary catheter
- Diagnosed UTI within the previous 21 days
- Antibiotic therapy within the previous 21 days
- Use of phenazopyridine within the previous 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 |
|---|---|---|
| DNA PCRGene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms. | Device | DNA Polymerase Chain Reaction (PCR) |
| Urine CultureUrine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture. | Diagnostic test | Urine Culture |
Primary outcome
Change in symptoms as measured by UTI-SIQ-8 questionnaire
Time frame: Baseline, one day after antibiotic completion
The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.
Change in symptoms as measured by the UTI Symptom Assessment questionnaire
Time frame: Baseline, one day after antibiotic completion
The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.
6 secondary outcomes
Length of time from patient presentation to initiation of treatment as measured by medical record review
Time frame: Up to 21 days
Number of antibiotic changes as measured by medical record review
Time frame: Up to 21 days
Duration of antibiotic use as measured by medical record review
Time frame: Up to 21 days
Number of times participant represents with UTI symptoms as measured by medical record review
Time frame: Up to 30 days
Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review
Time frame: Up to 21 days
Number of hospitalizations related to UTI as measured by medical record review
Time frame: Up to 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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.
David Sheyn, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA PCR and Urine Culture in people with Urinary Tract Infections, run by University Hospitals Cleveland Medical Center 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana N Mitchell, MD, MBA, BSN (216-844-1000, diana.mitchell@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms as measured by UTI-SIQ-8 questionnaire (time frame: Baseline, one day after antibiotic completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.