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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04108910
• Other study ID #: 2019 R-VPA-HUS
• Status: Completed
• Start date: March 2016
• Est. completion date: April 2020

Study information

• Verified date: April 2024
• Source: Pathnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66381
• Est. completion date: April 2020
• Est. primary completion date: July 2019
• Gender: All
• Age group: 18 Years to 111 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

Diagnostic Test:
• Guidance UTI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pathnostics

References & Publications (8)

Anderson JE. Seasonality of symptomatic bacterial urinary infections in women. J Epidemiol Community Health. 1983 Dec;37(4):286-90. doi: 10.1136/jech.37.4.286. — View Citation

Gharbi M, Drysdale JH, Lishman H, Goudie R, Molokhia M, Johnson AP, Holmes AH, Aylin P. Antibiotic management of urinary tract infection in elderly patients in primary care and its association with bloodstream infections and all cause mortality: population based cohort study. BMJ. 2019 Feb 27;364:l525. doi: 10.1136/bmj.l525. — View Citation

Hsiao CY, Yang HY, Chang CH, Lin HL, Wu CY, Hsiao MC, Hung PH, Liu SH, Weng CH, Lee CC, Yen TH, Chen YC, Wu TC. Risk Factors for Development of Septic Shock in Patients with Urinary Tract Infection. Biomed Res Int. 2015;2015:717094. doi: 10.1155/2015/717094. Epub 2015 Aug 25. — View Citation

Kolman KB. Cystitis and Pyelonephritis: Diagnosis, Treatment, and Prevention. Prim Care. 2019 Jun;46(2):191-202. doi: 10.1016/j.pop.2019.01.001. — View Citation

Qiang XH, Yu TO, Li YN, Zhou LX. Prognosis Risk of Urosepsis in Critical Care Medicine: A Prospective Observational Study. Biomed Res Int. 2016;2016:9028924. doi: 10.1155/2016/9028924. Epub 2016 Feb 3. — View Citation

Simmering JE, Cavanaugh JE, Polgreen LA, Polgreen PM. Warmer weather as a risk factor for hospitalisations due to urinary tract infections. Epidemiol Infect. 2018 Feb;146(3):386-393. doi: 10.1017/S0950268817002965. Epub 2018 Jan 8. — View Citation

Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998-2011. Open Forum Infect Dis. 2017 Feb 24;4(1):ofw281. doi: 10.1093/ofid/ofw281. eCollection 2017 Winter. — View Citation

Suskind AM, Saigal CS, Hanley JM, Lai J, Setodji CM, Clemens JQ; Urologic Diseases of America Project. Incidence and Management of Uncomplicated Recurrent Urinary Tract Infections in a National Sample of Women in the United States. Urology. 2016 Apr;90:50-5. doi: 10.1016/j.urology.2015.11.051. Epub 2016 Jan 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify the frequency of observed polymicrobial infections	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
Primary	ER Visits and or Hospital Admission Rate within 30 days of initial visit related to UTI	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	Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity.	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

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