CompletedNot Applicable

Evaluating UTI Outcomes in at Risk Populations

United States7,921 participantsStarted 2022-07-18

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

UTI-related ED visit and/or hospitalization within 30 days of index visit

Timeframe: within 30 days of index visit

Composite of adverse events associated with index UTI event

Timeframe: 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.

Timeframe: within 30 days of index visit

Trial details

NCT IDNCT05385536

SponsorPathnostics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-03-29

View on ClinicalTrials.gov More Urinary Tract Infections trials