NCT03931538

Brief Summary

In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,511

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

April 25, 2019

Last Update Submit

August 24, 2023

Conditions

Urinary Tract InfectionsProstatitisInterstitial Cystitis

Keywords

UTIIC

Outcome Measures

Primary Outcomes (1)

  • Establish Safety: composite adverse event rate

    Demonstrate safety of Guidance 4.0 multiplex real-time PCR organism identification with mixed floral antibiotic resistance profiling guided treatment. Safety will be measured with a composite adverse event outcome of urosepsis, pyelonephritis, hospitalization, or the need to attend an urgent care center. The composite adverse event rate in the arm tested with Guidance 4.0 will be shown to be non-inferior to that in the arm tested with traditional urine culture. Superiority will also be tested.

    7 Days

Secondary Outcomes (2)

  • Number of Patients with Recurrent and Persistent Infections in Each Arm

    7 Days

  • Time to Symptom Resolution in Each Arm

    7 days

Other Outcomes (1)

  • Physician Choice for Decision Making when Provided Both Results

    4 Months

Study Arms (4)

Culture Only

ACTIVE COMPARATOR

Physician receives only culture result

Diagnostic Test: Urine Culture

Guidance 4.0 PCR test only

ACTIVE COMPARATOR

Physician receives Guidance report only

Diagnostic Test: Guidance 4.0 PCR test

Culture and Guidance 4.0 PCR test Group

ACTIVE COMPARATOR

Physician receives both results, gets Culture report immediately before Guidance

Diagnostic Test: Guidance 4.0 PCR testDiagnostic Test: Urine Culture

Guidance 4.0 PCR test and culture group

ACTIVE COMPARATOR

Physician receives both results, gets Guidance report immediately before culture

Diagnostic Test: Guidance 4.0 PCR testDiagnostic Test: Urine Culture

Interventions

Guidance 4.0 PCR testDIAGNOSTIC_TEST

All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.

Culture and Guidance 4.0 PCR test GroupGuidance 4.0 PCR test and culture groupGuidance 4.0 PCR test only
Urine CultureDIAGNOSTIC_TEST

All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.

Culture OnlyCulture and Guidance 4.0 PCR test GroupGuidance 4.0 PCR test and culture group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient Informed Consent form completed
  • Male and Female Subjects may participate with no predetermined quotas or ratios for gender participation.
  • All patients must be ≥60 years old. For patients presenting with a diagnosis of interstitial cystitis, patients may be of any age.
  • Patients must be presenting for treatment of acute UTI, complicated UTI, persistent UTI, or recurrent UTI's.
  • Including prostatitis, pyelonephritis, and/or interstitial cystitis.
  • Data pertaining to the times at which the specimen samples are collected and stabilized needs to be documented.
  • Specimen samples obtained need to have a sufficient volume necessary to perform a urine culture and Guidance 4.0.

You may not qualify if:

  • Do not provide written informed Consent with HIPAA authorization form.
  • Taking antibiotics for any reason other than UTI at the time of enrollment
  • Patients with chronic (\> 10 days) indwelling catheters
  • Self-catheterized patients
  • Patients with neobladders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Urology

Royal Oak, Michigan, 48037, United States

Location

MeSH Terms

Conditions

Urinary Tract InfectionsProstatitisCystitis, Interstitial

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProstatic DiseasesGenital Diseases, MaleGenital DiseasesCystitisUrinary Bladder Diseases

Study Officials

  • Kirk Wojno, MD

    Comprehensive Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 30, 2019

Study Start

July 17, 2018

Primary Completion

February 22, 2019

Study Completion

October 1, 2019

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

US(1)