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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04108910
Enrollment
66381
Registered
2019-09-30
Start date
2016-03-31
Completion date
2020-04-30
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

UTI, Home Care

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTGuidance UTI

Sponsors

Pathnostics
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 111 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
ER Visits and or Hospital Admission Rate within 30 days of initial visit related to UTI18 MonthsExamine 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

MeasureTime frameDescription
Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity.18 MonthsExamine 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

MeasureTime frameDescription
Identify the frequency of observed polymicrobial infections18 MonthsIdentify 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026