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Trial record 1 of 1 for:    05091931
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Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting

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ClinicalTrials.gov Identifier: NCT05091931
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Pathnostics

Study Description
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Brief Summary:
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and improves therapeutic accuracy of treatment

Condition or disease
Urinary Tract Infections

Detailed Description:
We propose to conduct a multicenter, comparative cohort observational study to determine whether the use of Guidance® UTI Clinical Pathway compared with current traditional pathways for urine testing reduces the rates of empiric antibiotic therapy and improves therapeutic accuracy of treatment. Comparative outpatient Urology and urogynecology office cohorts will be allocated at an uneven 2:1 allocation ratio. Regardless of arm assignment, all outpatient offices have the option to order ANY diagnostic test for suspected UTI, this includes urine cultures and/or other molecular testing methods including Guidance® UTI. If a provider in the Guidance Clinical Pathway arm decides to order urine cultures instead of using the Guidance® UTI Clinical Pathway, those results will also be reported to the site lead, though TAT may take up to 72 hours to result per standard culture protocols. We will be observing the practice's implementation of the Clinical Pathway and reporting infrastructure to provide rapid, centralized reporting to the ordering provider, allowing for efficient treatment. Guidance® UTI is currently widely available, and all participating outpatient offices (regardless of arm) will have the option to order this test.
Study Design
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Study Type : Observational
Estimated Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Cohort Study Comparing the Effects of Guidance® UTI vs. Culture-based Testing Methods on Antibiotic Prescribing Practices in an Outpatient Setting
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Guidance® UTI Pathway
Guidance® UTI testing pathway with antibiotic sensitivity and microbial testing results reporting to a clinical lead specialist at the urology office within 14 hours of lab receipt. Treatment based on local standard clinical antibiotic selection with or without empiric therapy.
Traditional Diagnostic Pathways
Local standard clinical practice pattern for UTI testing (e.g., urine analysis, urine culture and sensitivities or molecular testing as available) Treatment based on local standard clinical antibiotic selection with or without empiric therapy


Outcome Measures
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Primary Outcome Measures :
  1. The percentage of outpatients seen for suspected UTI started on empiric treatment [ Time Frame: 12 months ]
    To determine if Guidance® UTI pathway compared to traditional diagnostic pathways is associated with fewer empiric antibiotic treatments for patients with Complicated UTI in outpatient setting.

  2. Rate of Adverse Events through 30 days [ Time Frame: 12 months ]
    To determine if Guidance® UTI pathway compared to traditional diagnostic pathways is associated with lower rate in adverse events through 30 Days.


Secondary Outcome Measures :
  1. Resolution of the initial UTI symptoms by day 14 [ Time Frame: 12 months ]
    To determine if Guidance® UTI pathway compared to traditional diagnostic pathways is associated with faster symptom resolution within 14 days and higher rates of complete symptom resolution by day 30

  2. Complete Resolution of symptoms by day 30 [ Time Frame: 12 months ]
    To determine if Guidance® UTI pathway compared to traditional diagnostic pathways is associated higher rates of prescribed antibiotics that are concordant with sensitivity results.


Biospecimen Retention:   Samples With DNA
Data or specimens collected in this research study might be used for future research or distributed to another investigator for future research without your consent.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals >18 years requiring evaluation for suspected urinary tract infection in the urology or urogynecology practice.
Criteria

Inclusion Criteria:

  • Able to provide Informed Consent in English and Spanish.
  • Male and Female Subjects > 18 years of age may participate with no predetermined quotas or ratios for gender participation. Presenting to urologist or urogynecologist in outpatient setting with a history of complicated UTI (cUTI) and clinically suspected active UTI (e.g., UA positive for L.E. or nitrites) and based on clinical judgment require microbial testing.
  • Definition of cUTI- UTI is considered complicated when the individual has one or more risk factors that predispose to higher treatment failure and poor outcomes6. These poor outcomes include persistence of UTI, increasing severity, or occurrence of complications such as urosepsis, recurrence, and perinephric abscess.
  • Recurrent UTI is defined as 2 infections in 6 months or 3 infections in 12 months in a calendar year. A UTI at the index visit may be used towards this count.

Exclusion Criteria:

  • Patients with bladder/urologic cancer
  • Patients presenting with chronic pelvic pain
  • Patients presenting with untreated overactive bladder (either neurogenic or non-neurogenic)
  • Patients not meeting incl. criteria listed above.
  • Do not provide written informed Consent with HIPAA authorization form
  • Inability to independently provide symptom data
  • Patient must have email access to participate and complete in online surveys
  • Pregnancy
  • Incarceration
  • If the provider deems that a urine culture/ Guidance UTI is not necessary in clinical management, the patient is not eligible for enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091931


Contacts
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Contact: Mohit Mathur, MD,PhD (714) 966-1221 ext 615 MixedAgeStudy@pathnostics.com
Contact: Natalie Luke, PhD (714) 966-1221 MixedAgeStudy@pathnostics.com

Locations
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United States, Michigan
Comprehensive Urology Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Howard Korman, MD    248-336-1080      
Contact: Tarek Sangid, MD    248-336-1080      
Sponsors and Collaborators
Pathnostics
Investigators
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Principal Investigator: Dave Baunoch, PhD Clinical Trials
More Information
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Responsible Party: Pathnostics
ClinicalTrials.gov Identifier: NCT05091931    
Other Study ID Numbers: 2021-UTI-PMAS
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pathnostics:
Recurrent UTI
Complicated Urinary Tract Infection
C Difficile
Adverse Drug Event
Additional relevant MeSH terms:
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Urinary Tract Infections
Infections
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases