Urinary Tract InfectionsAt RiskNCT05385536
Evaluating UTI Outcomes in at Risk Populations
An observational study of Urinary Tract Infections and Complicated Urinary Tract Infection, run by Pathnostics at 1 site in United States.
Trial summary
This is a multicenter, observational comparative cohort, study to evaluate the UTI related adverse event rates between Guidance® UTI clinical pathway versus the current traditional clinical pathways for urine testing. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Tract Infections, Complicated Urinary Tract Infection
- How many people
- 7,921 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 29 Mar 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
- No healthy volunteers
- Older adult
Study population: Patients ≥ 65 years of age seen by healthcare professional for UTI
Who may be able to join
- Male or female participants ≥ 65 years of age, no predetermined quotas or ratios for gender participation.
- High suspicion of active UTI
- Ability to provide/obtain a clean catch or sterile urine specimen
- Willing to adhere to follow-up schedule as stated in schedule of events
- Permanent residence in the same state in which they were consented for the study
- Able to provide informed consent
Who cannot join
- Participation in another UTI trial during the study period
- Patients in hospice-care or limited life expectancy of ≤1 month)
- Inability to provide informed consent and/or respond independently to follow up surveys
- If the provider deems that a urine culture or Guidance UTI is not necessary in clinical management
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter, observational comparative cohort, study to evaluate the UTI related adverse event rates between Guidance® UTI clinical pathway versus the current traditional clinical pathways for urine testing.
Read the detailed description
Clinical sites will be identified by an internal database, prepared by the sponsor, based on previous experience with the sites. Study allocation will based on their current usage of Guidance® UTI and the reporting pathway (described above) will be implemented. Those who currently routinely use Guidance® UTI testing procedures will be over sampled 2:1 over those who do not routinely use Guidance® UTI. Larger clinical care systems with multiple care sites may have locations allocated to different cohort. The basis for cohort allocation will be based on the availability and willingness of providers in these markets to implement infrastructure for collecting and reporting of Guidance® UTI clinical pathway. The comparative cluster cohort will be selected from select geographies within the U.S. based on size of general population served matching to those enrolled in the Guidance® UTI clinical pathway.
The method of patient care and management (e.g., test ordering and antimicrobial initiation) is at the discretion of the treating physicians. Specimens collected for suspected UTI may be sent to Pathnostics for standard bacterial identification and sensitivities. Guidance® UTI can only be performed at Pathnostics, whereas urine cultures may be performed at any lab. Trained and experienced clinical lab scientists at Pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have.
- 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 | Sites 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. | |
| Traditional clinical pathway | Sites will employ their current standard clinical care practices for suspected UTI, including Standard Urine Culture (SUC), Urine Analysis (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.
UTI-related ED visit and/or hospitalization within 30 days of index visit
UTI-related ED visit and/or hospitalization within 30 days of index visit
Measured: within 30 days of index visit
Composite of adverse events associated with index UTI event
Composite of adverse events associated with index UTI event
Allergic reactions to antibiotic therapy
Progression to pyelonephritis
Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction
yeast infection (Vaginitis/vulvovaginal candidiasis)
Progression to acute renal failure
Tendinopathy (including tendon rupture)
- difficile infection
Sepsis
Measured: within 30 days of index visit
Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days.
Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days.
Measured: within 30 days of index visit
Secondary outcomes (4)
Rate of empirical antibiotic starts for UTI indication
Rate of empirical antibiotic starts for UTI indication
Measured: within 1 year of index visit
Rate of antimicrobial changes for UTI indication
Rate of antimicrobial changes for UTI indication
Measured: within 1 year of index visit
Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed.
Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed.
Measured: within 1 year of index visit
UTI-related ED visit and/or hospitalization within 1 year of index visit
UTI-related ED visit and/or hospitalization within 1 year of index visit
Measured: within 1 year of index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start18 Jul 2022
- Primary completion29 Mar 2024
- Study completion29 Mar 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
- 7,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385536
- Sponsor's protocol ID
- 2022-PARS
- Acronym
- At Risk
- Status last verified
- May 2024
- First submitted
- 12 May 2022
- Last updated
- 3 May 2024
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating UTI Outcomes in at Risk Populations
- ClinicalTrials.gov ID
- NCT05385536
- Acronym / sponsor ID
- At Risk / 2022-PARS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,921 participants (actual)
- Lead sponsor
- PathnosticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 23 May 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.
This is a multicenter, observational comparative cohort, study to evaluate the UTI related adverse event rates between Guidance® UTI clinical pathway versus the current traditional clinical pathways for urine testing.
Detailed description
Clinical sites will be identified by an internal database, prepared by the sponsor, based on previous experience with the sites. Study allocation will based on their current usage of Guidance® UTI and the reporting pathway (described above) will be implemented. Those who currently routinely use Guidance® UTI testing procedures will be over sampled 2:1 over those who do not routinely use Guidance® UTI. Larger clinical care systems with multiple care sites may have locations allocated to different cohort. The basis for cohort allocation will be based on the availability and willingness of providers in these markets to implement infrastructure for collecting and reporting of Guidance® UTI clinical pathway. The comparative cluster cohort will be selected from select geographies within the U.S. based on size of general population served matching to those enrolled in the Guidance® UTI clinical pathway.
The method of patient care and management (e.g., test ordering and antimicrobial initiation) is at the discretion of the treating physicians. Specimens collected for suspected UTI may be sent to Pathnostics for standard bacterial identification and sensitivities. Guidance® UTI can only be performed at Pathnostics, whereas urine cultures may be performed at any lab. Trained and experienced clinical lab scientists at Pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidance clinical pathway | – | –Sites 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. |
| Traditional clinical pathway | – | –Sites will employ their current standard clinical care practices for suspected UTI, including Standard Urine Culture (SUC), Urine Analysis (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
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥ 65 years of age seen by healthcare professional for UTI
Key inclusion criteria (6 listed)
- Male or female participants ≥ 65 years of age, no predetermined quotas or ratios for gender participation.
- High suspicion of active UTI
- Ability to provide/obtain a clean catch or sterile urine specimen
- Willing to adhere to follow-up schedule as stated in schedule of events
- Permanent residence in the same state in which they were consented for the study
Key exclusion criteria (4 listed)
- Participation in another UTI trial during the study period
- Patients in hospice-care or limited life expectancy of ≤1 month)
- Inability to provide informed consent and/or respond independently to follow up surveys
- If the provider deems that a urine culture or Guidance UTI is not necessary in clinical management
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
UTI-related ED visit and/or hospitalization within 30 days of index visit
Time frame: within 30 days of index visit
UTI-related ED visit and/or hospitalization within 30 days of index visit
Composite of adverse events associated with index UTI event
Time frame: within 30 days of index visit
Composite of adverse events associated with index UTI event Allergic reactions to antibiotic therapy Progression to pyelonephritis Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction yeast infection (Vaginitis/vulvovaginal candidiasis) Progression to acute renal failure Tendinopathy (including tendon rupture) C. difficile infection Sepsis
Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days.
Time frame: within 30 days of index visit
Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days.
4 secondary outcomes
Rate of empirical antibiotic starts for UTI indication
Time frame: within 1 year of index visit
Rate of antimicrobial changes for UTI indication
Time frame: within 1 year of index visit
Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed.
Time frame: within 1 year of index visit
UTI-related ED visit and/or hospitalization within 1 year of index visit
Time frame: within 1 year of index visit
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 3 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Complicated Urinary Tract Infection, 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 6 inclusion and 4 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 3 May 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?
UTI-related ED visit and/or hospitalization within 30 days of index visit (time frame: within 30 days of index visit). The study lists 3 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 3 May 2024.