Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
Completed
Conditions studied: Urinary Tract Infections
In brief
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
Key facts
- Study ID
- NCT05091931
- Run by
- Pathnostics
- People needed
- 3308
- Starts
- 2022-03-28
- Expected to finish
- 2024-09-19
- Last updated by the study team
- 2025-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to provide verbal informed consent
- Male and Female Subjects > 18 years of age may participate with no predetermined quotas or ratios for gender participation (Group 2).
- Male and Female Subjects > 18 and older may participate with no predetermined quotas or ratios for gender participation (Group 1).
- A history of complicated UTI (cUTI)**
- Must present at the time of enrollment with clinically suspected active UTI (any LUTS)
- Management requires microbial identification and sensitivities of urine
- *Definition of cUTI- A UTI is considered complicated when the individual has one or more risk factors that predispose to higher treatment failure and poor outcomes.6 These poor outcomes include persistence of UTI, increasing severity, or occurrence of complications such as urosepsis, recurrence, and perinephric abscess. Although the definition of cUTI may vary among current medical bodies and organizations, for this study, we define examples of cUTIs to include:
- UTIs in the elderly population due to increased chances of comorbidities and immune compromised state,
- Recurrent UTIs2, which is defined as the occurrence of ⩾2 symptomatic episodes within 6 months or ⩾3 symptomatic episodes within 12 months
- UTI in patients with anatomic or functional pathology affecting the urinary tract, such as an obstruction, hydronephrosis, renal tract calculi, or colovesical fistula
- UTIs occurring due to an immune compromised state, such as steroid use, post chemotherapy, diabetes, and HIV, and transplant recipients
- UTIs caused by atypical microorganisms or multi-drug resistant microorganisms. Typical UTI-causing microorganisms include E. coli, P. aeruginosa, several species within the Enterobacteriaceae family (Proteus and Klebsiella), and a few Gram- positive bacteria, such as Staphylococcus saprophyticus and Enterococcus faecalis, as well as fungi, such as Candida sp.7,5
- UTI in male: UTIs occurring despite the presence of anatomical protective measures as part of the male urinary tract anatomy are by definition cUTI,
- UTI in patients with history of radiotherapy to the abdomen or pelvis,
- UTIs occurring after instrumentation, nephrostomy tubes, ureteric stents, suprapubic tubes, or Foley catheters
- UTI in patients with the history of recurrent UTI,
- UTIs in patients with impaired renal function,
- UTIs following prostatectomies or radiotherapy
You may not qualify if…
- Patients with history of chronic pelvic pain syndrome/interstitial cystitis (Excluded in GROUP 2 only)
- Patients that are receiving radiation therapy in the pelvic region
- Patients with history of unstable, untreated, or are failing treatment for overactive bladder (either neurogenic or non-neurogenic)
- Patients with history of bladder malignancy in the past 3 years
- Patients that have been treated with chemotherapy in the past 3 years
- Inability to independently provide symptom data
- Patient must have email access if they choose to complete surveys online.
- Pregnancy
- Incarceration
Where it is running
- First Urology — Louisville, Kentucky, United States
- Comprehensive Urology — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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