Evaluating UTI Outcomes in at Risk Populations
- Conditions
- Complicated Urinary Tract InfectionUrinary Tract Infections
- Registration Number
- NCT05385536
- Lead Sponsor
- Pathnostics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7921
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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.
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
- Secondary Outcome Measures
Name Time Method 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 empirical antibiotic starts for UTI indication within 1 year of index visit Rate of empirical antibiotic starts for UTI indication
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.
Trial Locations
- Locations (1)
Dispatch Health
🇺🇸Denver, Colorado, United States