Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting

NCT05091931 | Completed

• 1 other identifier: 2021-UTI-PMAS
• Study Type: observational
• Target: 3,308
• Locations: 1 country
• Sites: 2

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

Conditions

Urinary Tract Infections

Keywords

Recurrent UTI; Complicated Urinary Tract Infection; C Difficile; Adverse Drug Event

Outcome Measures

Primary Outcomes (2)

• The percentage of outpatients seen for suspected UTI started on empiric treatment

  The percentage of outpatients seen for suspected UTI started on empiric treatment

  30 days

• Rate of Adverse Events through 30 days

  The incidence rate of the adverse events (listed below) 30 days following index visit. * Allergic reactions to antibiotic therapy * Nausea/vomiting, headache, skin rash, anaphylaxis/hypersensitivity reaction * yeast infection (Vaginitis/vulvovaginal candidiasis) * Acute renal failure * tendinopathy (including tendon rupture) * C. difficile infection * ED Visit/Urgent care (UTI) * Hospitalization (UTI) * Sepsis * Recurrent UTI (rUTI) - The proportion of subjects reporting recurrence of symptomatic UTI and receive antimicrobial treatment (re-prescription). All subjects having reported initial resolution of their UTI symptoms by day 14 will be assessed for this outcome.

  30 days

Secondary Outcomes (4)

• Resolution of the Initial UTI Symptoms by Day 14

  14 Days

• Resolution of Symptoms

  30 days

• Antibiotics Concordance with Sensitivity Results

  30 days

• Biomarkers

  30 days

Study Arms (3)

Guidance® UTI pathway (standard lab workflow)

Guidance® UTI pathway with antibiotic sensitivity and microbial testing results available to ordering provider within 48 hours of lab receipt. Includes confirmation by the clinical lead that the ordering provider has acted upon results as soon as they are made available. The lab will follow current workflows in terms of result reporting. Treatment based on local standard clinical antibiotic selection with or without empiric therapy.

Guidance® UTI pathway (modified lab workflow)

Guidance® UTI pathway with antibiotic sensitivity and microbial testing results reporting to a clinical lead specialist at the urology office within 14 hours of lab receipt. Includes confirmation by the clinical lead that the ordering provider has acted upon results as soon as they are made available. Treatment based on local standard clinical antibiotic selection with or without empiric therapy.

Traditional clinical pathway

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals \>18 years requiring evaluation for suspected urinary tract infection in the urology or urogynecology practice.

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

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

Sponsors & Collaborators

• Pathnostics: lead

Study Sites (2)

First Urology

Louisville, Kentucky, 40207, United States

Location

Comprehensive Urology

Royal Oak, Michigan, 48073, United States

Location

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.

MeSH Terms

Conditions

Urinary Tract Infections; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chemically-Induced Disorders

Study Officials

• Dave Baunoch, PhD

  Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: March 28, 2022
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)