Urinary Tract InfectionsNCT04815369
Evaluating UTI Diagnosis in Nursing Homes
An observational study of Urinary Tract Infections, run by Pathnostics at 1 site in United States.
Trial summary
This prospective, multicenter, comparative cohort observational study is to determine whether the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of UTI patients with… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 8 Nov 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Cohort of residents residing in the NH facility during 12 consecutive months.-
Who may be able to join
- Certified skilled nursing facilities (SNF) and nursing homes (NH)
- Nonprofit or for-profit freestanding facility certified by Medicare and Medicaid
- Currently utilizing an EMR system
- Minimum bed size of 100
Who cannot join
- Assisted Living Facilities and Residential Care Facilities
- Participation in another UTI trial during the study period
Trial locations and contacts
1 site in 1 country.
About this study
This prospective, multicenter, comparative cohort observational study is to determine whether the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of UTI patients with poor outcomes.
Read the detailed description
The objective of this study is to determine if prospective data, collected over 12 months from over 200 nursing homes, will show that the use of Guidance® UTI Clinical Pathway is more effective than the Traditional Clinical Pathways for urine testing in UTI diagnosis in Nursing Homes. Guidance® UTI Clinical Pathway provides standardized infrastructure for specimen collection, and result dissemination via assigned report point person to verify receipt of actionable data. The pathway also includes several in-services on molecular testing for UTI, Pooled Antibiotic Susceptibility Testing, and polymicrobial infections to help providers better understand test methodology. Standardizing a Clinical Care Pathway for testing and reporting of clinical results approach may lead to a reduction in empiric broad spectrum antibiotic use and in turn better health-related outcomes for patients. Such efficiency in clinical decision making at the time of initial presentation may lead to improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab diagnosis. The study will be observing the implementation of the Guidance® UTI Clinical Pathway and comparing it to traditional clinical care pathways from facility-level data entered into the National Healthcare Safety Network for its LTCF (Long Term Care Facilities) Component.
- Conditions
- Urinary Tract Infections
- Keywords
- Nursing Home, Clostridium difficile, PCR, Long Term Care Facility, Skilled Nursing Facility, National Healthcare Safety Network
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Guidance Clinical Pathway | Facilities will be provided a standardized infrastructure and process for collecting and reporting of urine test results including unique lab requisitions that contain the option to order Guidance® UTI, Standard Urine Culture (SUC), and Urine Analysis (UA) along with a protocol for results notification to a central point person within the Nursing Home (NH) facility | |
| Traditional Clinical Pathway | Facilities will employ their current standard clinical care practices for suspected UTI, including SUC, UA, and Guidance® UTI testing as per current reporting practices. Providers at these facilities will have the option to order any diagnostic test they deem appropriate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events.
Examine the proportion of patients with UTI-related adverse events requiring emergency hospital services over the course the study with a composite measure of the number of UTI related ED visits and/or subsequent hospitalizations and/or sepsis events.
Measured: 12 Months
Secondary outcomes (3)
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use.
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use as measured by the rate of empiric antibiotic starts and the rate of antimicrobial changes for UTI indication.
Measured: 30 Days
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management .
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management as measured by UTI incidence and corresponding urine testing rate
- (UTI and Catheter associated (CA)-UTI bacterial identification incidence rates (diagnostic aim)
- Population UTI Rate = (UTI Episodes/Resident Days) x 1,000
- CA-UTI Rate = (CA-UTI Episode/Catheter days) x 1,000
Measured: 12 Months
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects as measured by:
- C. diff event rate = (Total C. diff events/ total resident days) x 1,000
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 Mar 2021
- Study start7 Jun 2021
- Primary completion30 May 2024
- Study completion8 Nov 2024
Why it stopped: No Enrollment
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
- 0 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
- NCT04815369
- Sponsor's protocol ID
- 2021-PUTINH
- Status last verified
- Nov 2024
- First submitted
- 22 Mar 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
- Evaluating UTI Diagnosis in Nursing Homes
- ClinicalTrials.gov ID
- NCT04815369
- Acronym / sponsor ID
- 2021-PUTINH
- Conditions
- Urinary Tract Infections
- Keywords
- Nursing Home, Clostridium difficile, PCR, Long Term Care Facility, Skilled Nursing Facility, National Healthcare Safety Network
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PathnosticsIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 25 Mar 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 whether the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of UTI patients with poor outcomes.
Detailed description
The objective of this study is to determine if prospective data, collected over 12 months from over 200 nursing homes, will show that the use of Guidance® UTI Clinical Pathway is more effective than the Traditional Clinical Pathways for urine testing in UTI diagnosis in Nursing Homes. Guidance® UTI Clinical Pathway provides standardized infrastructure for specimen collection, and result dissemination via assigned report point person to verify receipt of actionable data. The pathway also includes several in-services on molecular testing for UTI, Pooled Antibiotic Susceptibility Testing, and polymicrobial infections to help providers better understand test methodology. Standardizing a Clinical Care Pathway for testing and reporting of clinical results approach may lead to a reduction in empiric broad spectrum antibiotic use and in turn better health-related outcomes for patients. Such efficiency in clinical decision making at the time of initial presentation may lead to improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab diagnosis. The study will be observing the implementation of the Guidance® UTI Clinical Pathway and comparing it to traditional clinical care pathways from facility-level data entered into the National Healthcare Safety Network for its LTCF (Long Term Care Facilities) Component.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidance Clinical Pathway | – | –Facilities will be provided a standardized infrastructure and process for collecting and reporting of urine test results including unique lab requisitions that contain the option to order Guidance® UTI, Standard Urine Culture (SUC), and Urine Analysis (UA) along with a protocol for results notification to a central point person within the Nursing Home (NH) facility |
| Traditional Clinical Pathway | – | –Facilities will employ their current standard clinical care practices for suspected UTI, including SUC, UA, and Guidance® UTI testing as per current reporting practices. Providers at these facilities will have the option to order any diagnostic test they deem appropriate. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Cohort of residents residing in the NH facility during 12 consecutive months.-
Key inclusion criteria (4 listed)
- Certified skilled nursing facilities (SNF) and nursing homes (NH)
- Nonprofit or for-profit freestanding facility certified by Medicare and Medicaid
- Currently utilizing an EMR system
- Minimum bed size of 100
Key exclusion criteria (2 listed)
- Assisted Living Facilities and Residential Care Facilities
- Participation in another UTI trial during the study period
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
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events.
Time frame: 12 Months
Examine the proportion of patients with UTI-related adverse events requiring emergency hospital services over the course the study with a composite measure of the number of UTI related ED visits and/or subsequent hospitalizations and/or sepsis events.
3 secondary outcomes
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use.
Time frame: 30 Days
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management .
Time frame: 12 Months
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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
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 Pathnostics 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 4 inclusion and 2 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: withdrawn, 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events. (time frame: 12 Months). 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.