Clinical trial NCT05385536: Evaluating UTI Outcomes in at Risk Populations
Official title: Evaluating UTI Outcomes in at Risk Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Complicated Urinary Tract Infection
Lead sponsor: Pathnostics
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 7921
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 65 years of age seen by healthcare professional for UTI

Brief 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.

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.

Eligibility criteria: Inclusion

* 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

Exclusion

* 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

Primary outcomes:
measure: UTI-related ED visit and/or hospitalization within 30 days of index visit
timeFrame: within 30 days of index visit
measure: Composite of adverse events associated with index UTI event
timeFrame: within 30 days of index visit
measure: Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription) within 30 days.
timeFrame: within 30 days of index visit
Secondary outcomes:
measure: Rate of empirical antibiotic starts for UTI indication
timeFrame: within 1 year of index visit
measure: Rate of antimicrobial changes for UTI indication
timeFrame: within 1 year of index visit
measure: Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed.
timeFrame: within 1 year of index visit
measure: UTI-related ED visit and/or hospitalization within 1 year of index visit
timeFrame: within 1 year of index visit
Other outcomes:
Locations:
city: Denver
country: United States
facility: Dispatch Health
state: Colorado
Study officials:
References: