Urinary Tract InfectionsNCT06750666
The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals
An observational study of Urinary Tract Infections and Diagnostic Techniques and Procedures, run by Jacob Bodilsen at 2 sites in Denmark.
Trial summary
The goal of this interrupted time-series analysis is to evaluate the impact of the de-implementation of urine dipsticks as a diagnostic tool for urinary tract infections (UTIs) in hospitalized patients in the North Denmark Region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Diagnostic Techniques and Procedures, Point-of-Care Testing
- What is being tested?
- De-implementation of Urinary Dipsticks
- How many people
- 480,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 26 Oct 2026to 31 Dec 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A primary inclusion criterion is that adult patients (≥18 years of age) begin their admission in one of the four emergency rooms in the North Denmark Region. Three of these are part of Aalborg University Hospital, located in Hobro, Aalborg, and Thisted, while the fourth is at Hjørring, part of the North Denmark Regional Hospital. Patients arrive at the emergency rooms either through referrals from general practitioners or directly via emergency calls. Following admission, patients may be discharged or transferred to an inpatient unit, including internal medicine, abdominal surgery, or urological surgery departments. Other surgical departments (e.g., orthopedic surgery), emergency rooms for orthopedic injuries ("skadestuer"), and pediatric departments (<18 years) are not included in this study.
Who may be able to join
- All patients admitted to emergency rooms (≥18 years) from 2019 and forward.
Who cannot join
- Patients directly admitted to an inpatient unit without first visiting an emergency room are excluded from the study.
- For the primary analysis, only the first admission will be included; subsequent admissions will be excluded.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg University Hospital
Aalborg, 9000
North Denmark Regional Hospital
Hjørring, 9800
About this study
Official title: The Impact of De-implementing Urine Dipsticks for Diagnosis of Urinary Tract Infections in the North Denmark Region: An Interrupted Time-series Analysis
The goal of this interrupted time-series analysis is to evaluate the impact of the de-implementation of urine dipsticks as a diagnostic tool for urinary tract infections (UTIs) in hospitalized patients in the North Denmark Region. The main question it aims to answer is:
How does de-implementation of urine dipsticks affect the diagnosis and management of UTIs and related disorders?
Read more
Specifically, does it change the following parameters:
- Number and severity of UTI infections (lower and upper UTI, non-severe and severe)
- Antibiotic prescription (overall, antibiotic classes, administration routes, duration, dosages)
- Number of urine cultures and number of positive urine cultures
- Risks of admission to intensive care units and 30-day mortality
- Risk of drug toxicity
- Length of hospital stay
- Risk of admission to intensive care unit
- 30-day risk of readmission after discharge
- 6-month risks of Clostridioides difficile enterocolitis and de novo antimicrobial resistance in cultures obtained during routine clinical care.
Researchers hypothesize that de-implementing urine dipsticks will lead to a reduced frequency of diagnosed cystitis, reduced antibiotic use, and fewer urine cultures without negatively affecting patient mortality or readmission risk.
Researchers will compare the outcomes before and after the discontinuation of urine dipsticks across hospitals in the North Denmark Region. Furthermore, results will be compared to another Danish administrative healthcare region where dipsticks are still in use as well as urine culture data from the primary sector in the North Denmark Region.
Since this is a registry-based observational study utilizing data from the electronic patient record system in the North Denmark Region, no direct contact will be made with participants.
Read the detailed description
BACKGROUND:
Urinary tract infections (UTIs) are a leading cause of antibiotic treatment and hospitalizations in Europe and the United States. Urine dipsticks are a widely used point-of-care test in hospitals, with over half of admitted patients in the North Denmark Region being screened using this method. They are considered an effective tool to rule out UTIs and aim to save resources by reducing unnecessary urine cultures and guiding initial antibiotic choice when used correctly. However, for reliable results, urine dipsticks require specific preanalytical conditions, such as a clean midstream sample retained in the bladder for 4-6 hours before voiding. These criteria are rarely met in clinical practice. Moreover, the prevalence of asymptomatic bacteriuria among hospitalized patients is about 45% which requires careful interpretation and correlation with specific symptoms of UTI by the clinician.
Although designed to rule out UTIs, studies suggest that urine dipsticks are often misused to rule them in, despite their low positive predictive value in hospital settings. This misuse may contribute to excessive antibiotic use. Furthermore, despite their generally high negative predictive value, a recent study in the North Denmark Region found that negative dipsticks cannot reliably exclude UTIs in symptomatic patients.
Due to these limitations, urine dipsticks were de-implemented throughout the North Denmark Region in August 2023 and February 2024. In September 2024, the Danish Society of Infectious Diseases and the Danish Society of Clinical Microbiology recommended discontinuing dipstick use in all Danish hospitals. However, the impact of de-implementing such a widely used point-of-care test remains unknown, raising questions about whether the advantages of this decision outweigh its potential drawbacks.
AIM This study aims to assess the impact of removing urine dipsticks in hospitals in the North Denmark Region.
HYPOTHESES
- The incidence of urine cultures will decrease after the de-implementation of the urine dipstick.
- The incidence of the ICD-10 codes, DN300 (acute cystitis), DN308C (recurrent cystitis), DN309 (unspecific cystitis), and DA419B (urosepsis) will decrease after the de-implementation of the urine dipstick.
- The overall use of antibiotics as well as UTI-specific antibiotics, pivmecillinam, nitrofurantoin, sulfamethizol, and trimethoprim, will decrease after the de-implementation of the urine dipstick.
- Risk of admission into the intensive care unit will remain unchanged before and after the de-implementation of the urine dipstick.
- The average length of hospital stay and mortality rate will remain unchanged before and after the de-implementation of the urine dipstick.
- Risk of early readmissions, defined as a return to an inpatient unit or emergency room within 30 days after the initial discharge, will remain the same before and after the de-implementation of the urine dipstick.
In a subpopulation of patients with positive urine cultures, the investigators hypothesize that:
- The mortality rate and average length of stay will remain unchanged after the de-implementation of the urine dipstick.
- The proportion of patients treated with antibiotics with uropathogenic coverage will remain the same before and after the de-implementation of the dipsticks (the UTI-specific antibiotics presented above and/or ampicillin/gentamicin, piperacillin/tazobactam or ciprofloxacin).
METHODS Design This study will be a registry-based interrupted time-series analysis utilizing data from the Business Intelligence Portal in the North Denmark Region. Data before and after the abolishment of the dipsticks will be extracted.
Setting Exposure The de-implementation of urine dipsticks in North Denmark Region in August 2023 (Aalborg) and February 2024 (Hjørring).
Study period Data will be extracted from both emergency rooms and inpatient units. The data extraction will start when the Business Intelligence Portal can extract data (preferably from 2019), and end at the latest update of conducting the study.
This study will include two control groups:
- A comparable hospital cohort from the Central Denmark Region.
- The total number of urine cultures requested by general practitioners in the North Denmark Region during the study period.
STATISTICS To avoid duplicates, the primary analysis will only include each patient's first admission during the study period.
Descriptive statistics: Incidence rates
Since hospitalized patients are an open cohort, the incidence rates (e.g. of antibiotic use), will be calculated using the following formula:
Monthly incidence rate of pivmecillinam use=((Number of unique persons treated with pivmecillinam))/(Amount of total person time in a month)=X pr.1000 patient days
Confidence intervals of the incidence rates will be calculated based on the Poisson distribution, and the standard error will be calculated as:
Standard error (log〖rate)=1/√(number of cases)〗 The total incidence rates will be standardized using direct standardization based on the age distribution of the patient population as of September 2024 (the latest available data at the time of writing this protocol).
Mortality
Mortality rates will be calculated using the same methodology as presented above. In a supplementary analysis, the investigators will calculate the 30-day mortality risk:
30-day mortality risk=(Number of deaths within 30 days)/(Total number of admissions)=X %
And the case-fatality rate:
Case fatality=(Number of deaths in the hospital)/(Total number of admissions)=X %
Charlson Severity Index The medical history extracted up to 10 years before the index date, will be extracted to calculate the Charlson Comorbidity Index using standard methodology.
Comparisons The incidence and mortality rates in the North Denmark Region before and after the de-implementation of the dipstick will be compared using the principles of interrupted time series regression. This methodology offers the advantage of adjusting for seasonality. Furthermore, the rates in the North Denmark Region will be compared to those in the control groups.
- Conditions
- Urinary Tract Infections, Diagnostic Techniques and Procedures, Point-of-Care Testing, Anti-Bacterial Agents, Registry, Clinical Decision-making
- Being tested
- De-implementation of Urinary Dipsticks, Usual practice with no intervention
- Keywords
- Urine Dipstick De-implementation, Urinary Tract Infections, Hospital, Registry-Based Study, Clinical Impact, urine dipsticks
- 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.
De-implementation of Urinary DipsticksDiagnostic test
In August 2023 / February 2024, urinary dipsticks were de-implemented in hospitals across the North Denmark Region. Using registry-based data, the investigators aim to evaluate the clinical impact of this decision.
Usual practice with no interventionOther
In hospitals within the Central Denmark Region and in the primary care sector, urinary dipsticks have not been de-implemented and remain in use. Registry-based data from these settings will serve as a control.
| Study group | Role | What they receive |
|---|---|---|
| Emergency rooms in North Denmark Region | Data from all emergency rooms in North Denmark Region will be retrieved. This includes sites at Aalborg University Hospital and North Denmark Regional Hospital. Receives: Diagnostic Test: De-implementation of Urinary Dipsticks | |
| Control hospital in Central Denmark Region | The investigators aim to retrieve data from a hospital outside the North Denmark Region that continues to use urine dipsticks. Specifically, the investigators plan to collect data from Aarhus University Hospital, the largest hospital in the Central Denmark Region. Receives: Other: Usual practice with no intervention | |
| Control urine cultures from general practice | The count of urine cultures ordered in the primary sector outside hospitals in the North Denmark Region (general practice), where dipsticks remain in use, will serve as a control. Receives: Other: Usual practice with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Incidence Rate of Urinary Tract Diagnoses (Composite Measure)
The monthly count of urinary tract infection diagnoses (ICD-10 codes: DN300, DN308C, DN309, DA419B) will be divided by the total person-time contributed by all admitted patients to the hospitals.
The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.
Measured: The monthly incidence will be calculated between January 2019 to end of the study (September 2025)
Monthly Incidence Rate of Urine Cultures (Composite Measure)
The monthly count of urine cultures (including all cultures, both positive and negative) will be divided by the total person-time contributed by admitted patients. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.
Measured: The monthly incidence will be calculated between January 2019 to end of the study period (September 2025)
Monthly Incidence Rate of Antibiotic Usage (Composite Measure)
The monthly count of urinary tract infection-specific antibiotic use (pivmecillinam, nitrofurantoin, sulfamethizole, and trimethoprim) will be divided by the total person-time contributed by all admitted patients to the hospitals. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.
Measured: The monthly incidence rate will be calculated between January 2019 to end of the study period (September 2025)
Monthly Mortality Rate (Composite Measure)
The monthly count of deaths will be divided by the total person-time contributed by admitted patients. The resulting mortality rate will be expressed as the number of deaths per 1000 patient-days.
Measured: The monthly mortality rate will be calculated between January 2019 to end of the study period (September 2025)
Monthly Incidence Rate of Readmissions (Composite Measure)
The monthly count of readmissions, defined as a return to an inpatient unit or emergency room within 30 days after the initial discharge, will be divided by the total person-time contributed by admitted patients. The resulting incidence rate will be expressed as the number of readmissions per 1000 patient-days.
Measured: The monthly incidence rate of readmissions will be calculated between January 2019 and the end of the study period (September 2025)
Median Length of Hospital Stay
The length of hospital stay will be measured in days for each admitted patient. The monthly median and interquartile range will be calculated over the study period.
Measured: The monthly median will be calculated from January 2019 to the end of the study period (September 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start26 Oct 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 480,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Jacob Bodilsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacob Bodilsen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750666
- Sponsor's protocol ID
- De-implementing Dipsticks
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: By Danish law, individual registry-based data cannot be shared. However, anonymized and aggregated composite data may be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of De-implementing Urine Dipsticks for Diagnosis of Urinary Tract Infections in the North Denmark Region: An Interrupted Time-series Analysis
- ClinicalTrials.gov ID
- NCT06750666
- Acronym / sponsor ID
- De-implementing Dipsticks
- Conditions
- Urinary Tract Infections, Diagnostic Techniques and Procedures, Point-of-Care Testing, Anti-Bacterial Agents, Registry, Clinical Decision-making
- Keywords
- Urine Dipstick De-implementation, Urinary Tract Infections, Hospital, Registry-Based Study, Clinical Impact, urine dipsticks
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 480,000 participants (estimated)
- Lead sponsor
- Jacob BodilsenUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Dec 2024 (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.
The goal of this interrupted time-series analysis is to evaluate the impact of the de-implementation of urine dipsticks as a diagnostic tool for urinary tract infections (UTIs) in hospitalized patients in the North Denmark Region. The main question it aims to answer is:
How does de-implementation of urine dipsticks affect the diagnosis and management of UTIs and related disorders?
Specifically, does it change the following parameters:
- Number and severity of UTI infections (lower and upper UTI, non-severe and severe)
- Antibiotic prescription (overall, antibiotic classes, administration routes, duration, dosages)
- Number of urine cultures and number of positive urine cultures
- Risks of admission to intensive care units and 30-day mortality
- Risk of drug toxicity
- Length of hospital stay
- Risk of admission to intensive care unit
- 30-day risk of readmission after discharge
- 6-month risks of Clostridioides difficile enterocolitis and de novo antimicrobial resistance in cultures obtained during routine clinical care.
Researchers hypothesize that de-implementing urine dipsticks will lead to a reduced frequency of diagnosed cystitis, reduced antibiotic use, and fewer urine cultures without negatively affecting patient mortality or readmission risk.
Researchers will compare the outcomes before and after the discontinuation of urine dipsticks across hospitals in the North Denmark Region. Furthermore, results will be compared to another Danish administrative healthcare region where dipsticks are still in use as well as urine culture data from the primary sector in the North Denmark Region.
Since this is a registry-based observational study utilizing data from the electronic patient record system in the North Denmark Region, no direct contact will be made with participants.
Detailed description
BACKGROUND:
Urinary tract infections (UTIs) are a leading cause of antibiotic treatment and hospitalizations in Europe and the United States. Urine dipsticks are a widely used point-of-care test in hospitals, with over half of admitted patients in the North Denmark Region being screened using this method. They are considered an effective tool to rule out UTIs and aim to save resources by reducing unnecessary urine cultures and guiding initial antibiotic choice when used correctly. However, for reliable results, urine dipsticks require specific preanalytical conditions, such as a clean midstream sample retained in the bladder for 4-6 hours before voiding. These criteria are rarely met in clinical practice. Moreover, the prevalence of asymptomatic bacteriuria among hospitalized patients is about 45% which requires careful interpretation and correlation with specific symptoms of UTI by the clinician.
Although designed to rule out UTIs, studies suggest that urine dipsticks are often misused to rule them in, despite their low positive predictive value in hospital settings. This misuse may contribute to excessive antibiotic use. Furthermore, despite their generally high negative predictive value, a recent study in the North Denmark Region found that negative dipsticks cannot reliably exclude UTIs in symptomatic patients.
Due to these limitations, urine dipsticks were de-implemented throughout the North Denmark Region in August 2023 and February 2024. In September 2024, the Danish Society of Infectious Diseases and the Danish Society of Clinical Microbiology recommended discontinuing dipstick use in all Danish hospitals. However, the impact of de-implementing such a widely used point-of-care test remains unknown, raising questions about whether the advantages of this decision outweigh its potential drawbacks.
AIM This study aims to assess the impact of removing urine dipsticks in hospitals in the North Denmark Region.
HYPOTHESES
- The incidence of urine cultures will decrease after the de-implementation of the urine dipstick.
- The incidence of the ICD-10 codes, DN300 (acute cystitis), DN308C (recurrent cystitis), DN309 (unspecific cystitis), and DA419B (urosepsis) will decrease after the de-implementation of the urine dipstick.
- The overall use of antibiotics as well as UTI-specific antibiotics, pivmecillinam, nitrofurantoin, sulfamethizol, and trimethoprim, will decrease after the de-implementation of the urine dipstick.
- Risk of admission into the intensive care unit will remain unchanged before and after the de-implementation of the urine dipstick.
- The average length of hospital stay and mortality rate will remain unchanged before and after the de-implementation of the urine dipstick.
- Risk of early readmissions, defined as a return to an inpatient unit or emergency room within 30 days after the initial discharge, will remain the same before and after the de-implementation of the urine dipstick.
In a subpopulation of patients with positive urine cultures, the investigators hypothesize that:
- The mortality rate and average length of stay will remain unchanged after the de-implementation of the urine dipstick.
- The proportion of patients treated with antibiotics with uropathogenic coverage will remain the same before and after the de-implementation of the dipsticks (the UTI-specific antibiotics presented above and/or ampicillin/gentamicin, piperacillin/tazobactam or ciprofloxacin).
METHODS Design This study will be a registry-based interrupted time-series analysis utilizing data from the Business Intelligence Portal in the North Denmark Region. Data before and after the abolishment of the dipsticks will be extracted.
Setting Exposure The de-implementation of urine dipsticks in North Denmark Region in August 2023 (Aalborg) and February 2024 (Hjørring).
Study period Data will be extracted from both emergency rooms and inpatient units. The data extraction will start when the Business Intelligence Portal can extract data (preferably from 2019), and end at the latest update of conducting the study.
This study will include two control groups:
- A comparable hospital cohort from the Central Denmark Region.
- The total number of urine cultures requested by general practitioners in the North Denmark Region during the study period.
STATISTICS To avoid duplicates, the primary analysis will only include each patient's first admission during the study period.
Descriptive statistics: Incidence rates
Since hospitalized patients are an open cohort, the incidence rates (e.g. of antibiotic use), will be calculated using the following formula:
Monthly incidence rate of pivmecillinam use=((Number of unique persons treated with pivmecillinam))/(Amount of total person time in a month)=X pr.1000 patient days
Confidence intervals of the incidence rates will be calculated based on the Poisson distribution, and the standard error will be calculated as:
Standard error (log〖rate)=1/√(number of cases)〗 The total incidence rates will be standardized using direct standardization based on the age distribution of the patient population as of September 2024 (the latest available data at the time of writing this protocol).
Mortality
Mortality rates will be calculated using the same methodology as presented above. In a supplementary analysis, the investigators will calculate the 30-day mortality risk:
30-day mortality risk=(Number of deaths within 30 days)/(Total number of admissions)=X %
And the case-fatality rate:
Case fatality=(Number of deaths in the hospital)/(Total number of admissions)=X %
Charlson Severity Index The medical history extracted up to 10 years before the index date, will be extracted to calculate the Charlson Comorbidity Index using standard methodology.
Comparisons The incidence and mortality rates in the North Denmark Region before and after the de-implementation of the dipstick will be compared using the principles of interrupted time series regression. This methodology offers the advantage of adjusting for seasonality. Furthermore, the rates in the North Denmark Region will be compared to those in the control groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emergency rooms in North Denmark Region | – | Diagnostic Test: De-implementation of Urinary DipsticksData from all emergency rooms in North Denmark Region will be retrieved. This includes sites at Aalborg University Hospital and North Denmark Regional Hospital. |
| Control hospital in Central Denmark Region | – | Other: Usual practice with no interventionThe investigators aim to retrieve data from a hospital outside the North Denmark Region that continues to use urine dipsticks. Specifically, the investigators plan to collect data from Aarhus University Hospital, the largest hospital in the Central Denmark Region. |
| Control urine cultures from general practice | – | Other: Usual practice with no interventionThe count of urine cultures ordered in the primary sector outside hospitals in the North Denmark Region (general practice), where dipsticks remain in use, will serve as a control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A primary inclusion criterion is that adult patients (≥18 years of age) begin their admission in one of the four emergency rooms in the North Denmark Region. Three of these are part of Aalborg University Hospital, located in Hobro, Aalborg, and Thisted, while the fourth is at Hjørring, part of the North Denmark Regional Hospital. Patients arrive at the emergency rooms either through referrals from general practitioners or directly via emergency calls. Following admission, patients may be discharged or transferred to an inpatient unit, including internal medicine, abdominal surgery, or urological surgery departments. Other surgical departments (e.g., orthopedic surgery), emergency rooms for orthopedic injuries ("skadestuer"), and pediatric departments (<18 years) are not included in this study.
Key inclusion criteria (1 listed)
- All patients admitted to emergency rooms (≥18 years) from 2019 and forward.
Key exclusion criteria (2 listed)
- Patients directly admitted to an inpatient unit without first visiting an emergency room are excluded from the study.
- For the primary analysis, only the first admission will be included; subsequent admissions will be excluded.
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 |
|---|---|---|
| De-implementation of Urinary DipsticksIn August 2023 / February 2024, urinary dipsticks were de-implemented in hospitals across the North Denmark Region. Using registry-based data, the investigators aim to evaluate the clinical impact of this decision. | Diagnostic test | Emergency rooms in North Denmark Region |
| Usual practice with no interventionIn hospitals within the Central Denmark Region and in the primary care sector, urinary dipsticks have not been de-implemented and remain in use. Registry-based data from these settings will serve as a control. | Other | Control hospital in Central Denmark Region, Control urine cultures from general practice |
Primary outcome
Monthly Incidence Rate of Urinary Tract Diagnoses (Composite Measure)
Time frame: The monthly incidence will be calculated between January 2019 to end of the study (September 2025)
The monthly count of urinary tract infection diagnoses (ICD-10 codes: DN300, DN308C, DN309, DA419B) will be divided by the total person-time contributed by all admitted patients to the hospitals. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.
Monthly Incidence Rate of Urine Cultures (Composite Measure)
Time frame: The monthly incidence will be calculated between January 2019 to end of the study period (September 2025)
The monthly count of urine cultures (including all cultures, both positive and negative) will be divided by the total person-time contributed by admitted patients. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.
Monthly Incidence Rate of Antibiotic Usage (Composite Measure)
Time frame: The monthly incidence rate will be calculated between January 2019 to end of the study period (September 2025)
The monthly count of urinary tract infection-specific antibiotic use (pivmecillinam, nitrofurantoin, sulfamethizole, and trimethoprim) will be divided by the total person-time contributed by all admitted patients to the hospitals. The resulting incidence rate will be expressed as the number of cases per 1000 patient-days.
Monthly Mortality Rate (Composite Measure)
Time frame: The monthly mortality rate will be calculated between January 2019 to end of the study period (September 2025)
The monthly count of deaths will be divided by the total person-time contributed by admitted patients. The resulting mortality rate will be expressed as the number of deaths per 1000 patient-days.
Monthly Incidence Rate of Readmissions (Composite Measure)
Time frame: The monthly incidence rate of readmissions will be calculated between January 2019 and the end of the study period (September 2025)
The monthly count of readmissions, defined as a return to an inpatient unit or emergency room within 30 days after the initial discharge, will be divided by the total person-time contributed by admitted patients. The resulting incidence rate will be expressed as the number of readmissions per 1000 patient-days.
Median Length of Hospital Stay
Time frame: The monthly median will be calculated from January 2019 to the end of the study period (September 2025).
The length of hospital stay will be measured in days for each admitted patient. The monthly median and interquartile range will be calculated over the study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. By Danish law, individual registry-based data cannot be shared. However, anonymized and aggregated composite data may be shared upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 and Diagnostic Techniques and Procedures, run by Jacob Bodilsen at 2 sites in Denmark.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Monthly Incidence Rate of Urinary Tract Diagnoses (Composite Measure) (time frame: The monthly incidence will be calculated between January 2019 to end of the study (September 2025)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.