Evaluating UTI Outcomes in at Risk Populations

Urinary Tract Infections Clinical Trial

— At Risk  

Official title:

Evaluating UTI Outcomes in at Risk Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385536
• Other study ID #: 2022-PARS
• Status: Completed
• Start date: July 18, 2022
• Est. completion date: March 29, 2024

Study information

• Verified date: May 2024
• Source: Pathnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7921
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Urinary Tract Infection
• Infections
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Dispatch Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Pathnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 30 days of index visit
Primary	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); C. difficile infection; Sepsis	within 30 days of index visit
Primary	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.	within 30 days of index visit
Secondary	Rate of empirical antibiotic starts for UTI indication	Rate of empirical antibiotic starts for UTI indication	within 1 year of index visit
Secondary	Rate of antimicrobial changes for UTI indication	Rate of antimicrobial changes for UTI indication	within 1 year of index visit
Secondary	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.	within 1 year of index visit
Secondary	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	within 1 year of index visit