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Completed

NCT Number: NCT04108910

Morbidity Rate for UTI 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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–111 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guidance UTI

Diagnostic Test

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pathnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 30, 2019
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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