Morbidity Rate for UTI Through Use of PCR-Based Diagnosis and Management

April 1, 2024 updated by: Pathnostics

Reduction in Morbidity Rate for Urinary Tract Infections Through Use of PCR-Based Diagnosis and Management

This retrospective study is to determine if the use of PCR for detection and identification of pathogens in UTI along with antimicrobial susceptibility information, affords more efficacious treatment of UTI, as compared to traditional urine culture for patients served by House Call Physicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine if retrospective data will show that use of PCR for detection and identification of pathogens in UTI, and antimicrobial susceptibility information, affords more efficacious treatment of UTI, thereby reducing UTI-related morbidity and costs in a patient population that is served by House Call Physicians. House call physicians attend elderly and other adults patients who are suffering from illness or chronic conditions in the safety, privacy, and comfort of their home or assisted living location. In making house calls, physicians ease the burden and difficulty of these chronic patients from traveling to the doctor's office.

Study Type

Observational

Enrollment (Actual)

66381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who are visited by a House Call Physician and attend to elderly and other adults patients who are suffering from illness or chronic conditions in the safety, privacy, and comfort of their home or assisted living location.

Description

Inclusion Criteria:

  • All patients that the House Call Physician suspects the patient has a UTI and are tagged with the following codes within the medical record

Exclusion Criteria:

  • Records where the NPI does not match a known provider or the office listed is not a Specific Population
  • Hospice patients
  • Records for which DX codes of "X" and "NoDx" where there isn't a diagnostic description.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional Urine Culture
Patients treated based upon traditional urine culture
Guidance PCR/Pooled Sensitivity
Patients treated based upon multiplex UTI PCR/pooled sensitivity results
Diagnostic test: Guidance UTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ER Visits and or Hospital Admission Rate within 30 days of initial visit related to UTI
Time Frame: 18 Months
Examine retrospective data of a House Call Patient population to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity, as measured by the composite variable number of emergency room/urgent care clinic visits plus the number of admissions to hospital within 30 days of an initial presentation for UTI.
18 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity.
Time Frame: 18 Months

Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity:

  • As measured by the number of emergency room visits within 30 days of an initial presentation for UTI.
  • As measured by the number of urgent care clinic visits within 30 days of an initial presentation for UTI.
  • As measured by the number of cases escalated from an urgent care clinic to an emergency room within 30 days of an initial presentation for UTI.
  • As measured by the number of admissions to hospital within 30 days of initial presentation for UTI.
  • As measured by the total hospital length of stay resulting from hospital admission within 30 days of initial presentation for UTI.
18 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the frequency of observed polymicrobial infections
Time Frame: 18 Months

Identify the frequency of observed polymicrobial infections (defined as two or more simultaneous bacterial infections), as determined by PCR testing, will be estimated for the population of patients with panel-confirmed UTIs.

Identify and compare the range and frequency of bacteria species detected by PCR or Traditional Culture within the population of patients.

Determine if use of PCR and pooled sensitivity provides a different number of options for antibiotic treatment.

Determine if specific bacteria are more commonly associated with hospital admissions.

Determine if specific bacteria are more commonly associated with longer length of hospital stay.
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pathnostics

Investigators

  • Principal Investigator: Kirk Wojno, MD, Visiting Physicians Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019 R-VPA-HUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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