Urinary Tract InfectionsNCT03270540
Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
An observational study of Urinary Tract Infections and UTI, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in children with first episode of UTI. Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children with UTI. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Urinary Tract Infections, UTI
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 13 Mar 2017to 18 Nov 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 Up to 3 years
- All sexes
- Child
Study population: children with UTI treated in Medical University of Warsaw Children's Hospital
Who may be able to join
- laboratory diagnosis of UTI in a child (positive leucocyturia and significant bacteriuria)
Who cannot join
- known previous UTIs
- known congenital abnormality of the kidney and the urinary tract (CAKUT)
Trial locations and contacts
1 site in 1 country.
About this study
Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in children with first episode of UTI.
Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more invasive tests. The timing of USG in UTI depends on the clinical situation. It always should be performed urgently when serious acute complications of UTI are suspected. However, appropriate timing of USG in children responding well to therapy, is a matter of debate. According to animal studies, E. coli produces toxin which dilates the urinary tract. This may result in misleading picture on USG in acute phase of infection. Guidelines on UTI management in children differ in respect to recommended USG timing.
Read more
The purpose of the study is to investigate how UTI does affect USG results in children and when its effect subsides.
Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in our study. Three USG examinations will be performed by single radiologist in every child:
- in the first day of treatment,
- two weeks after treatment initiation,
- four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein concentration and white blood cells count will be included in statistical analysis.
The study is aimed to help clinicians interpret USG findings during UTI and make reasonable plans for further imaging diagnostics in children with UTI.
- Conditions
- Urinary Tract Infections, UTI
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
USG abnormality persistence
significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start13 Mar 2017
- Primary completion18 Nov 2018
- Study completion18 Nov 2018
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 Medical University of WarsawThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Okarska-Napierała, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270540
- Sponsor's protocol ID
- WarsawMU2W9
- Status last verified
- Nov 2018
- First submitted
- 29 Aug 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
- ClinicalTrials.gov ID
- NCT03270540
- Acronym / sponsor ID
- WarsawMU2W9
- Conditions
- Urinary Tract Infections, UTI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 18 Nov 2018 (actual)
- Study completion
- 18 Nov 2018 (actual)
- First posted
- 1 Sep 2017 (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.
Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in children with first episode of UTI.
Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more invasive tests. The timing of USG in UTI depends on the clinical situation. It always should be performed urgently when serious acute complications of UTI are suspected. However, appropriate timing of USG in children responding well to therapy, is a matter of debate. According to animal studies, E. coli produces toxin which dilates the urinary tract. This may result in misleading picture on USG in acute phase of infection. Guidelines on UTI management in children differ in respect to recommended USG timing.
The purpose of the study is to investigate how UTI does affect USG results in children and when its effect subsides.
Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in our study. Three USG examinations will be performed by single radiologist in every child:
- in the first day of treatment,
- two weeks after treatment initiation,
- four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein concentration and white blood cells count will be included in statistical analysis.
The study is aimed to help clinicians interpret USG findings during UTI and make reasonable plans for further imaging diagnostics in children with UTI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- children with UTI treated in Medical University of Warsaw Children's Hospital
Key inclusion criteria (1 listed)
- laboratory diagnosis of UTI in a child (positive leucocyturia and significant bacteriuria)
Key exclusion criteria (2 listed)
- known previous UTIs
- known congenital abnormality of the kidney and the urinary tract (CAKUT)
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
USG abnormality persistence
Time frame: 4 weeks
significant abnormalities within kidney size or calices/pelvis/ureter dimensions, reproducible in subsequent USG examinations
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 26 Nov 2018.
- National Institute for Health and Care Excellence. Urinary tract infections in children and young people 2013 JulyLink provided by the sponsor.
- European Association of Urology; European Society for Pediatric Urology Urinary tract infections in children: (EAU/ESPU) guidelines.Link provided by the sponsor.
- Canadian Paediatric Society, Urinary tract infection in infants and children: Diagnosis and managementLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 and UTI, run by Medical University of Warsaw at 1 site in Poland.
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: finished, as of the sponsor's last update on 26 Nov 2018. 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 Poland. 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?
USG abnormality persistence (time frame: 4 weeks). 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 26 Nov 2018.