Complicated Urinary Tract Infection, Urinary Tract Infections
Conditions
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.
Interventions
None listed
Sponsors
Pathnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UTI-related ED visit and/or hospitalization within 30 days of index visit | 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 | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of empirical antibiotic starts for UTI indication | within 1 year of index visit | Rate of empirical antibiotic starts for UTI indication |
| UTI-related ED visit and/or hospitalization within 1 year of index visit | within 1 year of index visit | UTI-related ED visit and/or hospitalization within 1 year of index visit |
| Rate of antimicrobial changes for UTI indication | within 1 year of index visit | Rate of antimicrobial changes for UTI indication |
| Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed. | within 1 year of index visit | Recurrent UTI within 1 year of index visit suspected UTI as measured by total antibiotics prescribed. |
Countries
United States
Outcome results
None listed