Urinary Tract InfectionsNCT04408976
Implementation Study With Decision Support Based on Data
An observational study of Urinary Tract Infections, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study evaluates the implementation of a machine learning based clinical decision support system for treatment of patients presenting with an urinary tract infection in general practice. The software was developed to support general practitioners in the choice of antibiotic regimen. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 16,824 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Nov 2017to 16 May 2018
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a urinary tract infection diagnosed by the general practitioner
Who may be able to join
- Patients with a urinary tract infection in general practice
- Age > 12 years.
Who cannot join
- No.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Institute for Health Services Research
Utrecht
About this study
Official title: Implementation Study With Machine Learning Based Decision Support Software for Treatment of Urinary Tract Infections in General Practice.
This study evaluates the implementation of a machine learning based clinical decision support system for treatment of patients presenting with an urinary tract infection in general practice. The software was developed to support general practitioners in the choice of antibiotic regimen.
- Conditions
- Urinary Tract Infections
- Keywords
- Machine learning, Clinical Decision Support Systems
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Software practices | Patients with urinary tract infection in practices using the clinical decision support software | |
| Control practices | Patients with urinary tract infection in practices not using the clinical decision support software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-recurrent UTI
A subsequent period of time after treatment, in which no new UTI treatment was needed
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start13 Nov 2017
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prospective
- Enrolment
- 16,824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pacmed BV, Zorgverzekeraar CZ, Zorgverzekeraar Zilveren Kruis, Zorgverzekeraar Menzis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Netherlands Instititute for Health Services Research
- Responsible party
- Principal investigator, Tn Bonten, Leiden University Medical Center
- Investigators
- Willem Herter, Study director, Leiden University Medical CenterTobias Bonten, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408976
- Sponsor's protocol ID
- P1746
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herter WE, Khuc J, Cina G, Knottnerus BJ, Numans ME, Wiewel MA, Bonten TN, de Bruin DP, van Esch T, Chavannes NH, Verheij RA. Impact of a Machine Learning-Based Decision Support System for Urinary Tract Infections: Prospective Observational Study in 36 Primary Care Practices. JMIR Med Inform. 2022 May 4;10(5):e27795. doi: 10.2196/27795.
PubMed 35507396
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Study With Machine Learning Based Decision Support Software for Treatment of Urinary Tract Infections in General Practice.
- ClinicalTrials.gov ID
- NCT04408976
- Acronym / sponsor ID
- P1746
- Conditions
- Urinary Tract Infections
- Keywords
- Machine learning, Clinical Decision Support Systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,824 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Pacmed BV, Zorgverzekeraar CZ, Zorgverzekeraar Zilveren Kruis, Zorgverzekeraar Menzis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Netherlands Instititute for Health Services Research
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 1 Jun 2020 (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 study evaluates the implementation of a machine learning based clinical decision support system for treatment of patients presenting with an urinary tract infection in general practice. The software was developed to support general practitioners in the choice of antibiotic regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Software practices | – | –Patients with urinary tract infection in practices using the clinical decision support software |
| Control practices | – | –Patients with urinary tract infection in practices not using the clinical decision support software |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a urinary tract infection diagnosed by the general practitioner
Key inclusion criteria (2 listed)
- Patients with a urinary tract infection in general practice
- Age > 12 years.
Key exclusion criteria (1 listed)
- No.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-recurrent UTI
Time frame: 28 days
A subsequent period of time after treatment, in which no new UTI treatment was needed
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 1 Jun 2020.
- Derived from this study: PubMed 35507396Herter WE, Khuc J, Cina G, Knottnerus BJ, Numans ME, Wiewel MA, Bonten TN, de Bruin DP, van Esch T, Chavannes NH, Verheij RA. Impact of a Machine Learning-Based Decision Support System for Urinary Tract Infections: Prospective Observational Study in 36 Primary Care Practices. JMIR Med Inform. 2022 May 4;10(5):e27795. doi: 10.2196/27795.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Active, not recruitingObservational study
The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals
Urinary Tract Infections, Diagnostic Techniques and Procedures
RecruitingPhase 3
Precision Management of Urinary Tract Symptoms in Older Women
Urinary Tract Infection (Diagnosis)
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
Enrolling by invitation
VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
Common Infections, Urinary Tract Infections
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
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.
Willem Herter study director
Leiden University Medical Center
Tobias Bonten principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 inclusion and 1 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Non-recurrent UTI (time frame: 28 days). 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 NCT04408976, which also lists 1 linked publication.
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 1 Jun 2020.