Urinary Tract InfectionsNCT05814250
Ultrasonography in Children With First Febrile Urinary Tract Infection
An observational study of Urinary Tract Infections, run by IRCCS Burlo Garofolo at 3 sites in Italy.
Trial summary
In recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (fUTI) in children, including kidney ultrasound (KUS), cystography (VCUG) and renal scintigraphy in order to exclude underlying kidney anomalies. Read more about this study
- Who is it for?
- Ages 2 months to 3 years
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- 13 Jun 2022to 31 Mar 2028
- 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 2 months to 3 years
- All sexes
- Child
Study population: Children aged 2 months to 3 years with the first episode of urinary tract infection
Who may be able to join
- Patient with first episode of fUTI that subsequently do KUS.
Who cannot join
- patients with previous episodes of UTIs
- patients on antibiotic prophylaxis
- previous finding of malformative uropathies or cystic disease
- prenatal diagnosis of CAKUT with the following parameters: Presence of oligohydramnios, alterations in renal number, location and echo structure, bladder alteration, dilations of the renal pelvis and ureters
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
AOU Meyer IRCCS
Florence, 50139
Luigi Cirillo, MD, luigi.cirillo@meyer.it,
Francesca Beccherucci, MD, francesca.becherucci@gmail.com,
- Recruiting
IRCCS Policlinico Cà Granda
Milan
Giovanni Montini, Md, giovanni.montini@unimi.it
- Recruiting
IRCCS materno infantile Burlo Garofolo
Trieste, 34137
Marco Pennesi, MD, +39 040.3785.263, marco.pennesi@burlo.trieste.it
About this study
Official title: Is Ultrasonography Mandatory in All Children at Their First Febrile Urinary Tract Infection?
In recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (fUTI) in children, including kidney ultrasound (KUS), cystography (VCUG) and renal scintigraphy in order to exclude underlying kidney anomalies. The majority of guidelines, continue to recommend a routine KUS for all children at the first fUTI. On the other hand, as this approach is not based on robust evidence, other guidelines suggest that KUS should only be performed on selected patients according to specific risks. Despite being a non-invasive and radiation-free method, KUS tests negative in 83% of cases of fUTIs and possesses low specificity for low grade vesico-ureteral reflux (VUR). Since VUR is the most commonly associated renal malformation with UTI, it is evident that all the guidelines focus on the research of VUR, especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract (CAKUT). However, VUR-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar. To reduce the number of normal VCUGs performed, recent evidence regarding VUR suggests that the presence of pathogens different from E. coli and UTI recurrence may help to identify children who necessitate further investigations. A preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first fUTI who subsequently underwent US evaluation of the kidneys and urinary tract, found that atypical germ and recurrence of UTI exhibits a 85% sensitivity to detect pathological ultrasound. The aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of UTI in predicting the positivity of KUS in children aged 2 months to 3 years old with first episode of fUTI
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary tract infection, Kidney ultrasound, Congenital anomalies of the kidney and urinary tract
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic accuracy of the presence of an atypical germ combined with the possible recurrence of UTI in predicting the positivity of KUS in children aged between 2 months and 3 years with first episode of fUTI
Sensitivity, specificity positive and negative predictive values will be evaluated. Patient will be recruited prospectively. A first sample of urine culture can be collected from urine bag, and analyzed by urine dipstick. If urine dipstick tests positive such as positivity for leukocytes and/or nitrites, a second sample will be collected with sterile methods as clan catch or bladder catheterization. Urine culture will be performed in both urine samples. In case of a UTI a subsequent follow up is recommended with an abdominal ultrasound after one month. In case of a pathological ultrasound, the subsequent diagnostic follow up it is up to the clinician, with voiding cystography or scintigraphy. During the follow up period UTI relapses will be detected.
Measured: Follow up of 2 years or until the third year of age
Secondary outcomes (2)
To evaluate the diagnostic accuracy of urinary culture carried out from urinary bag vs a second sample gathered from the same patient by clean catch or bladder catheterization (gold standard)
Sensitivity, specificity positive and negative predictive values will be evaluated
Measured: At the time of urine collection (baseline)
To evaluate the concordance of the germs found in positive urinary culture carried out from urinary bag vs clean catch or bladder catheterization gathered from the same patient
The concordance of the germs found with the two different samples collections will be evaluated using the Cohen's kappa coefficient
Measured: At the time of urine collection (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start13 Jun 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2028 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Pennesi, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814250
- Sponsor's protocol ID
- RC 01/22
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2023
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Ultrasonography Mandatory in All Children at Their First Febrile Urinary Tract Infection?
- ClinicalTrials.gov ID
- NCT05814250
- Acronym / sponsor ID
- RC 01/22
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary tract infection, Kidney ultrasound, Congenital anomalies of the kidney and urinary tract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Apr 2023 (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.
In recent decades, different tests have been recommended by guidelines in the management of first febrile urinary tract infection (fUTI) in children, including kidney ultrasound (KUS), cystography (VCUG) and renal scintigraphy in order to exclude underlying kidney anomalies. The majority of guidelines, continue to recommend a routine KUS for all children at the first fUTI. On the other hand, as this approach is not based on robust evidence, other guidelines suggest that KUS should only be performed on selected patients according to specific risks. Despite being a non-invasive and radiation-free method, KUS tests negative in 83% of cases of fUTIs and possesses low specificity for low grade vesico-ureteral reflux (VUR). Since VUR is the most commonly associated renal malformation with UTI, it is evident that all the guidelines focus on the research of VUR, especially in times when antenatal ultrasound allows to screen for major congenital anomalies of kidney and urinary tract (CAKUT). However, VUR-associated nephropathy appears to be related to primary dysplastic damage rather than to be secondary to the reflux itself and not preventable from antibiotic prophylaxis in terms of recurrence and of kidney scar. To reduce the number of normal VCUGs performed, recent evidence regarding VUR suggests that the presence of pathogens different from E. coli and UTI recurrence may help to identify children who necessitate further investigations. A preliminary retrospective monocentric study enrolling all patients aged 2 to 36 months diagnosed with first fUTI who subsequently underwent US evaluation of the kidneys and urinary tract, found that atypical germ and recurrence of UTI exhibits a 85% sensitivity to detect pathological ultrasound. The aim of this multicentric study is to prospectively evaluate the diagnostic accuracy of the presence of atypical germ combined with the recurrence of UTI in predicting the positivity of KUS in children aged 2 months to 3 years old with first episode of fUTI
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 months to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged 2 months to 3 years with the first episode of urinary tract infection
Key inclusion criteria (1 listed)
- Patient with first episode of fUTI that subsequently do KUS.
Key exclusion criteria (4 listed)
- patients with previous episodes of UTIs
- patients on antibiotic prophylaxis
- previous finding of malformative uropathies or cystic disease
- prenatal diagnosis of CAKUT with the following parameters: Presence of oligohydramnios, alterations in renal number, location and echo structure, bladder alteration, dilations of the renal pelvis and ureters
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
To evaluate the diagnostic accuracy of the presence of an atypical germ combined with the possible recurrence of UTI in predicting the positivity of KUS in children aged between 2 months and 3 years with first episode of fUTI
Time frame: Follow up of 2 years or until the third year of age
Sensitivity, specificity positive and negative predictive values will be evaluated. Patient will be recruited prospectively. A first sample of urine culture can be collected from urine bag, and analyzed by urine dipstick. If urine dipstick tests positive such as positivity for leukocytes and/or nitrites, a second sample will be collected with sterile methods as clan catch or bladder catheterization. Urine culture will be performed in both urine samples. In case of a UTI a subsequent follow up is recommended with an abdominal ultrasound after one month. In case of a pathological ultrasound, the subsequent diagnostic follow up it is up to the clinician, with voiding cystography or scintigraphy. During the follow up period UTI relapses will be detected.
2 secondary outcomes
To evaluate the diagnostic accuracy of urinary culture carried out from urinary bag vs a second sample gathered from the same patient by clean catch or bladder catheterization (gold standard)
Time frame: At the time of urine collection (baseline)
To evaluate the concordance of the germs found in positive urinary culture carried out from urinary bag vs clean catch or bladder catheterization gathered from the same patient
Time frame: At the time of urine collection (baseline)
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 12 Jun 2024.
- 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.
Marco Pennesi, MD study director
IRCCS materno infantile Burlo Garofolo
3 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, run by IRCCS Burlo Garofolo at 3 sites in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Contact Marco Pennesi, MD (+39 040.3785.263, marco.pennesi@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic accuracy of the presence of an atypical germ combined with the possible recurrence of UTI in predicting the positivity of KUS in children aged between 2 months and 3 years with first episode of fUTI (time frame: Follow up of 2 years or until the third year of age). 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 12 Jun 2024.