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
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|Condition or disease|
|Urinary Tract Infections|
|Study Type :||Observational|
|Estimated Enrollment :||1700 participants|
|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|
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
- 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.
- 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.
- 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
- 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
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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|
- 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.
- 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
- If the provider deems that a urine culture/ Guidance UTI is not necessary in clinical management, the patient is not eligible for enrollment.
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
|Contact: Mohit Mathur, MD,PhD||(714) 966-1221 ext 615||MixedAgeStudy@pathnostics.com|
|Contact: Natalie Luke, PhD||(714) 966-1221||MixedAgeStudy@pathnostics.com|
|United States, Michigan|
|Royal Oak, Michigan, United States, 48073|
|Contact: Howard Korman, MD 248-336-1080|
|Contact: Tarek Sangid, MD 248-336-1080|
|Principal Investigator:||Dave Baunoch, PhD||Clinical Trials|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Complicated Urinary Tract Infection
Adverse Drug Event
Urinary Tract Infections
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases