Urinary Tract InfectionsNCT04108910
Morbidity Rate for UTI Through Use of PCR-Based Diagnosis and Management
An observational study of Urinary Tract Infections, run by Pathnostics.
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. Read more about this study
- Who is it for?
- Ages 18 to 111 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Guidance UTI
- How many people
- 66,381 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 111 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All patients that the House Call Physician suspects the patient has a UTI and are tagged with the following codes within the medical record
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Guidance UTI
- Keywords
- UTI, Home Care
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidance UTIDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Traditional Urine Culture | Patients treated based upon traditional urine culture | |
| Guidance PCR/Pooled Sensitivity | Patients treated based upon multiplex UTI PCR/pooled sensitivity results Receives: Diagnostic Test: Guidance UTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startMar 2016
- Primary completionJul 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirk Wojno, MD, Principal investigator, Visiting Physicians Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108910
- Sponsor's protocol ID
- 2019 R-VPA-HUS
- Status last verified
- Apr 2024
- First submitted
- 26 Sep 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26825489Simmering 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.
PubMed 28480273Qiang 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.
PubMed 26955639Gharbi 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.
PubMed 30814048Hsiao 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.
PubMed 26380292Simmering 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.
PubMed 29307331Anderson 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.
PubMed 6655418Kolman KB. Cystitis and Pyelonephritis: Diagnosis, Treatment, and Prevention. Prim Care. 2019 Jun;46(2):191-202. doi: 10.1016/j.pop.2019.01.001.
PubMed 31030820
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Morbidity Rate for Urinary Tract Infections Through Use of PCR-Based Diagnosis and Management
- ClinicalTrials.gov ID
- NCT04108910
- Acronym / sponsor ID
- 2019 R-VPA-HUS
- Conditions
- Urinary Tract Infections
- Keywords
- UTI, Home Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66,381 participants (actual)
- Lead sponsor
- PathnosticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Urine Culture | – | –Patients treated based upon traditional urine culture |
| Guidance PCR/Pooled Sensitivity | – | Diagnostic Test: Guidance UTIPatients treated based upon multiplex UTI PCR/pooled sensitivity results |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients that the House Call Physician suspects the patient has a UTI and are tagged with the following codes within the medical record
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guidance UTI | Diagnostic test | Guidance PCR/Pooled Sensitivity |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 26825489Suskind 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.
- Background: PubMed 28480273Simmering 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.
- Background: PubMed 26955639Qiang 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.
- Background: PubMed 30814048Gharbi 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.
- Background: PubMed 26380292Hsiao 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.
- Background: PubMed 29307331Simmering 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.
- Background: PubMed 6655418Anderson 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.
- Background: PubMed 31030820Kolman KB. Cystitis and Pyelonephritis: Diagnosis, Treatment, and Prevention. Prim Care. 2019 Jun;46(2):191-202. doi: 10.1016/j.pop.2019.01.001.
- A Diagnostics Solution CompanyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk Wojno, MD principal investigator
Visiting Physicians Association
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Pathnostics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ER Visits and or Hospital Admission Rate within 30 days of initial visit related to UTI (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108910, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.