Evaluating UTI Outcomes in at Risk Populations (At Risk)

• ClinicalTrials.gov Identifier: NCT05385536
• Recruitment Status: Not yet recruiting
• First Posted: May 23, 2022
• Last Update Posted: June 7, 2022
• Sponsor: Pathnostics
• Information provided by (Responsible Party): Pathnostics

Study Description

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.

Condition or disease	Intervention/treatment
Urinary Tract Infections; Complicated Urinary Tract Infection	Diagnostic Test: Guidance UTI Test

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 34000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluating UTI Outcomes in at Risk Populations
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: June 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Guidance clinical pathway; Sites will be provided a standardized infrastructure and process for collecting and reporting of urine test results including unique lab requisitions that contain the option to order Guidance® UTI, Standard Urine Culture (SUC), and Urine Analysis (UA) along with a protocol for results notification.	Diagnostic Test: Guidance UTI Test; Guidance® UTI was designed at Pathnostics a CLIA certified/CAP-accredited lab for use clinically to detect bacterial DNA in the urine via M-PCR and to characterize genotypic/phenotypic antibiotic resistance. Microbes are reported semi-quantitatively as cells per milliliter. In addition to bacterial identification, an antimicrobial susceptibility profile is generated through a patented technique referred to as P-AST (pooled antibiotic susceptibility testing); a high-throughput, broth microdilution spectrophotometric assay applied to a panel of antibiotic agents' array on a microplate to determine the MIC of the polymicrobial culture, if more than organism is present. Guidance® UTI is approved by CLIA for use and therefore is not IUO or RUO. Both components of the Guidance® UTI are analytically validated.
Traditional clinical pathway; Sites will employ their current standard clinical care practices for suspected UTI, including Standard Urine Culture (SUC), Urine Analysis (UA), and Guidance® UTI testing as per current reporting practices. Providers at these facilities will have the option to order any diagnostic test they deem appropriate.

Outcome Measures

Primary Outcome Measures :

1. Guidance® UTI clinical pathway will change the proportion of patients with UTI-related adverse events. [ Time Frame: within 30 days of index visit ]
   UTI-related ED visit and/or hospitalization change within 30 days of index visit
2. Guidance® UTI clinical pathway will change the proportion of patients with UTI-related adverse events. [ Time Frame: within 30 days of index visit ]

   Composite of adverse events associated with index UTI event and change in:

   1. Allergic reactions to antibiotic therapy
   2. Progression to pyelonephritis
   3. Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction
   4. yeast infection (Vaginitis/vulvovaginal candidiasis)
   5. Progression to acute renal failure
   6. Tendinopathy (including tendon rupture)
   7. C. difficile infection
   8. Sepsis
3. Guidance® UTI clinical pathway will change the proportion of patients with UTI-related adverse events. [ Time Frame: 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 Outcome Measures :

1. Guidance® UTI clinical pathway compared to current standard clinical care practices for suspected UTI, as measured by UTI-related adverse events, empiric antibiotic starts, and total antibiotics prescribed. [ Time Frame: within 1 year of index visit ]
   Guidance® UTI clinical pathway compared to current standard clinical care practices for suspected UTI as measured by UTI-related adverse events
2. Guidance® UTI clinical pathway compared to current standard clinical care practices for suspected UTI, as measured by UTI-related adverse events, empiric antibiotic starts, and total antibiotics prescribed. [ Time Frame: within 1 year of index visit ]
   Guidance® UTI clinical pathway compared to current standard clinical care practices for suspected UTI as measured by empiric antibiotic starts
3. Guidance® UTI clinical pathway compared to current standard clinical care practices for suspected UTI, as measured by UTI-related adverse events, empiric antibiotic starts, and total antibiotics prescribed. [ Time Frame: within 1 year of index visit ]
   Guidance® UTI clinical pathway compared to current standard clinical care practices for suspected UTI as measured by total antibiotics prescribed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 65 years of age seen by healthcare professional for UTI

Criteria

Inclusion Criteria:

• 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 Criteria:

• Participation in another UTI trial during the study period
• Patients in hospice-care or limited life expectancy of ≤1 month)
• Cognitively impaired or 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

Contacts and Locations

Contacts

Contact: Mohit Mathur, MD, Ph.D.; (714) 966-1221; AtRiskStudy@pathnostics.com

Contact: Natalie Luke, PhD; nluke@pathnostics.com

Sponsors and Collaborators

Pathnostics

More Information

• Responsible Party: Pathnostics
• ClinicalTrials.gov Identifier: NCT05385536
• Other Study ID Numbers: 2022-PARS
• First Posted: May 23, 2022
• Last Update Posted: June 7, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; Urinary Tract Infections; Disease Attributes; Pathologic Processes; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases