Urinary Tract InfectionsUTI_UCPNCT02368847
Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
A study testing Diagnostic tests in people with Urinary Tract Infections, run by KU Leuven.
Trial summary
Urinary tract infections are one of the most common types of infections in older persons. The general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Diagnostic tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older (65+ years) persons admitted to a gerontopsychiatric ward
Who cannot join
- Patients not understanding Dutch or not willing to participate (no informed consent)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimizing and Validating the Clinical Algorithm for Diagnosing Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
Urinary tract infections are one of the most common types of infections in older persons. The general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.
- Conditions
- Urinary Tract Infections
- Being tested
- Diagnostic tests
- Keywords
- Aged, Psychiatric Hospitals
- 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.
Diagnostic testsDevice
C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine C Reactive Protein level in the blood
Diagnostic testsDevice
Uricult dipslide: Easy-to-perform bacterial culture test for dectecting urinary tract infections in point of care settings
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic tests | Other | For any patient with a suspected urinary tract infection during the course of the study a basic questionnaire will have to be filled out and diagnostic tests (urine sample for culture, dipstick assay for the detection of nitrites and leukocyte- esterase and a POC CRP test) will have to be perform. Receives: Device: Diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious infection
To verify if the elderly has a serious infection, the research team will combine test results (dipstick, dipslide and CRP measurement) with signs/symptoms reported in the patient questionnaire.
Measured: 2 months
Secondary outcomes (1)
Reliability of the uricult dipslide in a population of institutionalized older patients
To verify the reliability of the uricult dipslide, a comparison will be made between the result of a dipslide read after 48h at room temperature, a dipslide incubated for 24h at +/- 35° Celsius and a urine culture test performed in a microbiology lab
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (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.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Latour Katrien, KU Leuven
- Investigators
- Jan De Lepeleire, PhD, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368847
- Sponsor's protocol ID
- UTI_UCP
- Acronym
- UTI_UCP
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing and Validating the Clinical Algorithm for Diagnosing Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
- ClinicalTrials.gov ID
- NCT02368847
- Acronym / sponsor ID
- UTI_UCP / UTI_UCP
- Conditions
- Urinary Tract Infections
- Keywords
- Aged, Psychiatric Hospitals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- 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.
Urinary tract infections are one of the most common types of infections in older persons. The general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic tests | Other | Device: Diagnostic testsFor any patient with a suspected urinary tract infection during the course of the study a basic questionnaire will have to be filled out and diagnostic tests (urine sample for culture, dipstick assay for the detection of nitrites and leukocyte- esterase and a POC CRP test) will have to be perform. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older (65+ years) persons admitted to a gerontopsychiatric ward
Key exclusion criteria (1 listed)
- Patients not understanding Dutch or not willing to participate (no informed consent)
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 |
|---|---|---|
| Diagnostic testsC Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine C Reactive Protein level in the blood | Device | Diagnostic tests |
| Diagnostic testsUricult dipslide: Easy-to-perform bacterial culture test for dectecting urinary tract infections in point of care settings | Device | Diagnostic tests |
Primary outcome
Serious infection
Time frame: 2 months
To verify if the elderly has a serious infection, the research team will combine test results (dipstick, dipslide and CRP measurement) with signs/symptoms reported in the patient questionnaire.
1 secondary outcome
Reliability of the uricult dipslide in a population of institutionalized older patients
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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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.
Jan De Lepeleire, PhD study director
KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic tests in people with Urinary Tract Infections, run by KU Leuven.
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 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: status not confirmed, as of the sponsor's last update on 23 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrien Latour, MSc (003226425762, katrien.latour@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious infection (time frame: 2 months). 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 23 Feb 2015.