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
1 other identifier
observational
66,381
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
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
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedApril 3, 2024
April 1, 2024
3.3 years
September 26, 2019
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity.
18 Months
Other Outcomes (1)
Identify the frequency of observed polymicrobial infections
18 Months
Study Arms (2)
Traditional Urine Culture
Patients treated based upon traditional urine culture
Guidance PCR/Pooled Sensitivity
Patients treated based upon multiplex UTI PCR/pooled sensitivity results
Interventions
Eligibility Criteria
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.
You may qualify if:
- All patients that the House Call Physician suspects the patient has a UTI and are tagged with the following codes within the medical record
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pathnosticslead
Related Publications (8)
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.
PMID: 26825489BACKGROUNDSimmering 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.
PMID: 28480273BACKGROUNDQiang 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.
PMID: 26955639BACKGROUNDGharbi 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.
PMID: 30814048BACKGROUNDHsiao 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.
PMID: 26380292BACKGROUNDSimmering 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.
PMID: 29307331BACKGROUNDAnderson 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.
PMID: 6655418BACKGROUNDKolman KB. Cystitis and Pyelonephritis: Diagnosis, Treatment, and Prevention. Prim Care. 2019 Jun;46(2):191-202. doi: 10.1016/j.pop.2019.01.001.
PMID: 31030820BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirk Wojno, MD
Visiting Physicians Association
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2019
First Posted
September 30, 2019
Study Start
March 1, 2016
Primary Completion
July 1, 2019
Study Completion
April 1, 2020
Last Updated
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share