Urinary Tract InfectionsNCT05091931
Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
An observational study of Urinary Tract Infections, run by Pathnostics at 2 sites in United States.
Trial summary
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and improves therapeutic accuracy of treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 3,308 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Mar 2022to 19 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals >18 years requiring evaluation for suspected urinary tract infection in the urology or urogynecology practice.
Who may be able to join
- Able to provide verbal informed consent
- Male and Female Subjects > 18 years of age may participate with no predetermined quotas or ratios for gender participation (Group 2).
- Male and Female Subjects > 18 and older may participate with no predetermined quotas or ratios for gender participation (Group 1).
- A history of complicated UTI (cUTI)**
- Must present at the time of enrollment with clinically suspected active UTI (any LUTS)
- Management requires microbial identification and sensitivities of urine
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- Definition of cUTI- A UTI is considered complicated when the individual has one or more risk factors that predispose to higher treatment failure and poor outcomes.6 These poor outcomes include persistence of UTI, increasing severity, or occurrence of complications such as urosepsis, recurrence, and perinephric abscess. Although the definition of cUTI may vary among current medical bodies and organizations, for this study, we define examples of cUTIs to include:
- UTIs in the elderly population due to increased chances of comorbidities and immune compromised state,
- Recurrent UTIs2, which is defined as the occurrence of ⩾2 symptomatic episodes within 6 months or ⩾3 symptomatic episodes within 12 months
- UTI in patients with anatomic or functional pathology affecting the urinary tract, such as an obstruction, hydronephrosis, renal tract calculi, or colovesical fistula
- UTIs occurring due to an immune compromised state, such as steroid use, post chemotherapy, diabetes, and HIV, and transplant recipients
- UTIs caused by atypical microorganisms or multi-drug resistant microorganisms. Typical UTI-causing microorganisms include E. coli, P. aeruginosa, several species within the Enterobacteriaceae family (Proteus and Klebsiella), and a few Gram- positive bacteria, such as Staphylococcus saprophyticus and Enterococcus faecalis, as well as fungi, such as Candida sp.7,5
- UTI in male: UTIs occurring despite the presence of anatomical protective measures as part of the male urinary tract anatomy are by definition cUTI,
- UTI in patients with history of radiotherapy to the abdomen or pelvis,
- UTIs occurring after instrumentation, nephrostomy tubes, ureteric stents, suprapubic tubes, or Foley catheters
- UTI in patients with the history of recurrent UTI,
- UTIs in patients with impaired renal function,
- UTIs following prostatectomies or radiotherapy
Who cannot join
- Patients with history of chronic pelvic pain syndrome/interstitial cystitis (Excluded in GROUP 2 only)
- Patients that are receiving radiation therapy in the pelvic region
- Patients with history of unstable, untreated, or are failing treatment for overactive bladder (either neurogenic or non-neurogenic)
- Patients with history of bladder malignancy in the past 3 years
- Patients that have been treated with chemotherapy in the past 3 years
- Inability to independently provide symptom data
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- Patient must have email access if they choose to complete surveys online.
- Pregnancy
- Incarceration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
First Urology
Louisville, Kentucky, 40207
Comprehensive Urology
Royal Oak, Michigan, 48073
About this study
Official title: A Prospective Observational Cohort Study Comparing the Effects of Guidance® UTI vs. Culture-based Testing Methods on Antibiotic Prescribing Practices in an Outpatient Setting
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and improves therapeutic accuracy of treatment
Read the detailed description
We propose to conduct a multicenter, comparative cohort observational study to determine whether the use of Guidance® UTI Clinical Pathway compared with current traditional pathways for urine testing reduces the rates of empiric antibiotic therapy and improves therapeutic accuracy of treatment. Comparative outpatient Urology and urogynecology office cohorts will be allocated at an uneven 2:1 allocation ratio. Regardless of arm assignment, all outpatient offices have the option to order ANY diagnostic test for suspected UTI, this includes urine cultures and/or other molecular testing methods including Guidance® UTI. If a provider in the Guidance Clinical Pathway arm decides to order urine cultures instead of using the Guidance® UTI Clinical Pathway, those results will also be reported to the site lead, though TAT may take up to 72 hours to result per standard culture protocols. We will be observing the practice's implementation of the Clinical Pathway and reporting infrastructure to provide rapid, centralized reporting to the ordering provider, allowing for efficient treatment. Guidance® UTI is currently widely available, and all participating outpatient offices (regardless of arm) will have the option to order this test.
- Conditions
- Urinary Tract Infections
- Keywords
- Recurrent UTI, Complicated Urinary Tract Infection, C Difficile, Adverse Drug Event
- Medical subject headings
- Urinary Tract Infections, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Guidance® UTI pathway (standard lab workflow) | Guidance® UTI pathway with antibiotic sensitivity and microbial testing results available to ordering provider within 48 hours of lab receipt. Includes confirmation by the clinical lead that the ordering provider has acted upon results as soon as they are made available. The lab will follow current workflows in terms of result reporting. Treatment based on local standard clinical antibiotic selection with or without empiric therapy. | |
| Guidance® UTI pathway (modified lab workflow) | Guidance® UTI pathway with antibiotic sensitivity and microbial testing results reporting to a clinical lead specialist at the urology office within 14 hours of lab receipt. Includes confirmation by the clinical lead that the ordering provider has acted upon results as soon as they are made available. Treatment based on local standard clinical antibiotic selection with or without empiric therapy. | |
| Traditional clinical pathway | Local standard clinical practice pattern for UTI testing (e.g., urine analysis, urine culture and sensitivities or molecular testing as available). Treatment based on local standard clinical antibiotic selection with or without empiric therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of outpatients seen for suspected UTI started on empiric treatment
The percentage of outpatients seen for suspected UTI started on empiric treatment
Measured: 30 days
Rate of Adverse Events through 30 days
The incidence rate of the adverse events (listed below) 30 days following index visit.
- Allergic reactions to antibiotic therapy
- Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction
- yeast infection (Vaginitis/vulvovaginal candidiasis)
- Acute renal failure
- tendinopathy (including tendon rupture)
- C. difficile infection
- ED Visit/Urgent care (UTI)
- Hospitalization (UTI)
- Sepsis
- Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription). All subjects having reported initial resolution of their UTI symptoms by day 14 will be assessed for this outcome.
Measured: 30 days
Secondary outcomes (4)
Resolution of the Initial UTI Symptoms by Day 14
Patients will be asked about UTI symptoms on days 1- 14 after index visit. Patients showing improvement in overall symptom score over 14 days versus baseline score. Subjects with persistent UTI symptoms or having received further antimicrobials because of UTI symptoms will be considered to have not met the outcome, whereas those without persistent UTI symptoms and not having received further antimicrobials will be considered to have met the outcome.
Measured: 14 Days
Resolution of Symptoms
Complete Resolution of symptoms by day 30
Measured: 30 days
Antibiotics Concordance with Sensitivity Results
Percentage of prescribed antibiotics that are concordant with sensitivity results
Measured: 30 days
Biomarkers
Number of samples containing biomarker concentration above specific thresholds; unique to each biomarker.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start28 Mar 2022
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
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.
- 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
- 3,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Baunoch, PhD, Principal investigator, Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091931
- Sponsor's protocol ID
- 2021-UTI-PMAS
- Status last verified
- May 2025
- First submitted
- 13 Oct 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study Comparing the Effects of Guidance® UTI vs. Culture-based Testing Methods on Antibiotic Prescribing Practices in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT05091931
- Acronym / sponsor ID
- 2021-UTI-PMAS
- Conditions
- Urinary Tract Infections
- Keywords
- Recurrent UTI, Complicated Urinary Tract Infection, C Difficile, Adverse Drug Event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,308 participants (actual)
- Lead sponsor
- PathnosticsIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 25 Oct 2021 (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.
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and improves therapeutic accuracy of treatment
Detailed description
We propose to conduct a multicenter, comparative cohort observational study to determine whether the use of Guidance® UTI Clinical Pathway compared with current traditional pathways for urine testing reduces the rates of empiric antibiotic therapy and improves therapeutic accuracy of treatment. Comparative outpatient Urology and urogynecology office cohorts will be allocated at an uneven 2:1 allocation ratio. Regardless of arm assignment, all outpatient offices have the option to order ANY diagnostic test for suspected UTI, this includes urine cultures and/or other molecular testing methods including Guidance® UTI. If a provider in the Guidance Clinical Pathway arm decides to order urine cultures instead of using the Guidance® UTI Clinical Pathway, those results will also be reported to the site lead, though TAT may take up to 72 hours to result per standard culture protocols. We will be observing the practice's implementation of the Clinical Pathway and reporting infrastructure to provide rapid, centralized reporting to the ordering provider, allowing for efficient treatment. Guidance® UTI is currently widely available, and all participating outpatient offices (regardless of arm) will have the option to order this test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guidance® UTI pathway (standard lab workflow) | – | –Guidance® UTI pathway with antibiotic sensitivity and microbial testing results available to ordering provider within 48 hours of lab receipt. Includes confirmation by the clinical lead that the ordering provider has acted upon results as soon as they are made available. The lab will follow current workflows in terms of result reporting. Treatment based on local standard clinical antibiotic selection with or without empiric therapy. |
| Guidance® UTI pathway (modified lab workflow) | – | –Guidance® UTI pathway with antibiotic sensitivity and microbial testing results reporting to a clinical lead specialist at the urology office within 14 hours of lab receipt. Includes confirmation by the clinical lead that the ordering provider has acted upon results as soon as they are made available. Treatment based on local standard clinical antibiotic selection with or without empiric therapy. |
| Traditional clinical pathway | – | –Local standard clinical practice pattern for UTI testing (e.g., urine analysis, urine culture and sensitivities or molecular testing as available). Treatment based on local standard clinical antibiotic selection with or without empiric therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals >18 years requiring evaluation for suspected urinary tract infection in the urology or urogynecology practice.
Key inclusion criteria (18 listed)
- Able to provide verbal informed consent
- Male and Female Subjects > 18 years of age may participate with no predetermined quotas or ratios for gender participation (Group 2).
- Male and Female Subjects > 18 and older may participate with no predetermined quotas or ratios for gender participation (Group 1).
- A history of complicated UTI (cUTI)**
- Must present at the time of enrollment with clinically suspected active UTI (any LUTS)
Key exclusion criteria (9 listed)
- Patients with history of chronic pelvic pain syndrome/interstitial cystitis (Excluded in GROUP 2 only)
- Patients that are receiving radiation therapy in the pelvic region
- Patients with history of unstable, untreated, or are failing treatment for overactive bladder (either neurogenic or non-neurogenic)
- Patients with history of bladder malignancy in the past 3 years
- Patients that have been treated with chemotherapy in the past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of outpatients seen for suspected UTI started on empiric treatment
Time frame: 30 days
The percentage of outpatients seen for suspected UTI started on empiric treatment
Rate of Adverse Events through 30 days
Time frame: 30 days
The incidence rate of the adverse events (listed below) 30 days following index visit. * Allergic reactions to antibiotic therapy * Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction * yeast infection (Vaginitis/vulvovaginal candidiasis) * Acute renal failure * tendinopathy (including tendon rupture) * C. difficile infection * ED Visit/Urgent care (UTI) * Hospitalization (UTI) * Sepsis * Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription). All subjects having reported initial resolution of their UTI symptoms by day 14 will be assessed for this outcome.
4 secondary outcomes
Resolution of the Initial UTI Symptoms by Day 14
Time frame: 14 Days
Resolution of Symptoms
Time frame: 30 days
Antibiotics Concordance with Sensitivity Results
Time frame: 30 days
Biomarkers
Time frame: 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 28 May 2025.
- 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.
Dave Baunoch, PhD principal investigator
Clinical Trials
2 sites 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 Pathnostics at 2 sites 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 18 inclusion and 9 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 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The percentage of outpatients seen for suspected UTI started on empiric treatment (time frame: 30 days). 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 28 May 2025.