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 range

65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

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

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