Urinary Tract InfectionsrUTINCT06482151
Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection
An observational study of Urinary Tract Infections, run by PENTA Foundation.
Trial summary
This is a multicentre, observational, epidemiological study in which infants within the first 3 months of life with UTI and children aged ≥4 months with r-UTI will be recruited from nephrology /emergency departments and primary care in European countries Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2025to 11 Mar 2025
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants 0 to < 4 months months of life with a presumptive UTI and children ≥4 months to < 18years with a presumptive recurrent UTI evaluated at participating sites will be eligible for the study if they fulfill all the criteria for suspected UTI diagnosis.
Who may be able to join
- Age between 0 weeks and 17 years
- Significant urine culture positive only for E. coli
- For infants up to 3 months of age, a confirmed first UTI episode as identified by urine culture obtained by a sterile method (as described above) and positive for E. coli only (no other pathogens)
- For children ≥4 months to < 18 years a confirmed rUTI episode as identified by urine culture obtained by a sterile method (as described above) and positive for E. coli only (no other pathogens)
- Collection of urine culture with a sterile method (suprapubic aspiration, bladder catheterization, clean voided urine)
- Signed informed consent form (signed by participant's legally authorized representative for participants who have not attained the age of majority)
- Signed Assent Form when appropriate, as determined by participant's age and individual site and country standards
Who cannot join
- Patients ≥18 years
- Children ≥ 4 months of age with a first UTI episode
- Absence of microbiological confirmation of UTI
- UTI caused by bacteria other than E. coli or polymicrobial culture
- Urine collected with a non-sterile method (urinary bag)
- UTI episode within 30 days of the end of antibiotic treatment for the previous UTI episode
- Second urine positive for E. coli during the same episode
- Patients in the active phase of anticancer treatment
About this study
Official title: Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection in Europe
This is a multicentre, observational, epidemiological study in which infants within the first 3 months of life with UTI and children aged ≥4 months with r-UTI will be recruited from nephrology /emergency departments and primary care in European countries
Read the detailed description
This is an international, multicenter, observational, cross-sectional epidemiological study.
Study participants will undergo a screening phase and will be checked for study eligible and inclusion/exclusion criteria at study entry. No other visits will be conducted other than the first evaluation. The study will be conducted across up to 26 participating sites in Europe, including nephrology departments, paediatric emergency departments and primary care centers. Specifically, sites located more in Western and Eastern Europe will be involved in the study. In total, 600 participants with rUTI (UTI) will be included in this study, with approximately 200 participants for each age group (from 0 months to < 3 years of age; from ≥ 3 to < 12 years of age, from ≥ 12 to < 18 years of age).
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract infections, recurrent urinary tract infections, infants, adolescents, Escherichia coli
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the serogroups of E. coli in the study cohort
The distribution [N (%)] of serotypes of E. coli in the study cohort will be evaluated separately for infants with UTI and children with r-UTI. Moreover, it will be evaluated separately for countries and age classification.
Measured: January 2027
Secondary outcomes (4)
To assess the clinical profile, especially comorbidities, of children with UTI and rUTI
The comorbidity profiles of children with urinary tract infections (UTIs) and recurrent UTIs (rUTIs) will be characterize using descriptive statistics. This will involve presenting the frequency and percentages [N (%) with Clopper-Pearson confidence interval] for each comorbidity within each group.
Measured: January 2027
• To assess the O-serotype distribution among drug-resistant E. coli, including multidrug resistant (MDR)
The number and percent (N [%]) of each O-serotype resistant to 0, 1, 2, 3, 4, and 5 antibiotic classes will be assessed. Antimicrobial susceptibility testing will use broth microdilution. Antibiotic panels will include antibiotics from 5 antimicrobial drug classes. Antibiotic resistance will be determined using minimal inhibitory concentration values and susceptibility criteria defined by either the Clinical and Laboratory Standards Institute (CLSI) or the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Measured: January 2027
To characterize drug resistance across O-serotypes of E. coli isolates that cause rUTIs in children
The resistance to representative antibiotics in the following 5 classes: aminoglycosides, cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, and sulfonamides will be reported. Based on these 5 classes (and representative antibiotics), the multidrug-resistant will be defined as isolates that were resistant to ≥3 of the 5 antibiotic classes listed. Resistance to last-resort antibiotics, carbapenems (doripenem, ertapenem, imipenem, and meropenem) and colistin will also be examined using Clinical and Laboratory Standards Institute breakpoints for minimum inhibitory concentration values.
Measured: January 2027
To evaluate the genetic characteristics of E. coli of children with r-UTI (WGS)
O genotyping will be conducted based on whole-genome sequencing, which will allow assessment of O-serotype at the genetic sequences level, following guidelines and using reference sequences described elsewhere (DebRoy et all 2016) . For isolates that either do not show a match or match with multiple known O serotypes, the O genotype will be designated as "non-determined." (Iguchi et al, 2014 ) All the evaluations will be performed overall and across countries and age categorizations. Moreover, the Kappa of Cohen will be used to assess the degree of agreement of the results between local laboratories and Central laboratory.
Measured: January 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start11 Mar 2025
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Why it stopped: Study terminated by the Funder
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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giovanni Montini, Prof., Study chair, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482151
- Sponsor's protocol ID
- rUTI
- Acronym
- rUTI
- Status last verified
- Apr 2025
- First submitted
- 25 Jun 2024
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection in Europe
- ClinicalTrials.gov ID
- NCT06482151
- Acronym / sponsor ID
- rUTI / rUTI
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract infections, recurrent urinary tract infections, infants, adolescents, Escherichia coli
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study terminated by the Funder
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 1 Jul 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.
This is a multicentre, observational, epidemiological study in which infants within the first 3 months of life with UTI and children aged ≥4 months with r-UTI will be recruited from nephrology /emergency departments and primary care in European countries
Detailed description
This is an international, multicenter, observational, cross-sectional epidemiological study.
Study participants will undergo a screening phase and will be checked for study eligible and inclusion/exclusion criteria at study entry. No other visits will be conducted other than the first evaluation. The study will be conducted across up to 26 participating sites in Europe, including nephrology departments, paediatric emergency departments and primary care centers. Specifically, sites located more in Western and Eastern Europe will be involved in the study. In total, 600 participants with rUTI (UTI) will be included in this study, with approximately 200 participants for each age group (from 0 months to < 3 years of age; from ≥ 3 to < 12 years of age, from ≥ 12 to < 18 years of age).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants 0 to < 4 months months of life with a presumptive UTI and children ≥4 months to < 18years with a presumptive recurrent UTI evaluated at participating sites will be eligible for the study if they fulfill all the criteria for suspected UTI diagnosis.
Key inclusion criteria (7 listed)
- Age between 0 weeks and 17 years
- Significant urine culture positive only for E. coli
- For infants up to 3 months of age, a confirmed first UTI episode as identified by urine culture obtained by a sterile method (as described above) and positive for E. coli only (no other pathogens)
- For children ≥4 months to < 18 years a confirmed rUTI episode as identified by urine culture obtained by a sterile method (as described above) and positive for E. coli only (no other pathogens)
- Collection of urine culture with a sterile method (suprapubic aspiration, bladder catheterization, clean voided urine)
Key exclusion criteria (8 listed)
- Patients ≥18 years
- Children ≥ 4 months of age with a first UTI episode
- Absence of microbiological confirmation of UTI
- UTI caused by bacteria other than E. coli or polymicrobial culture
- Urine collected with a non-sterile method (urinary bag)
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 assess the serogroups of E. coli in the study cohort
Time frame: January 2027
The distribution [N (%)] of serotypes of E. coli in the study cohort will be evaluated separately for infants with UTI and children with r-UTI. Moreover, it will be evaluated separately for countries and age classification.
4 secondary outcomes
To assess the clinical profile, especially comorbidities, of children with UTI and rUTI
Time frame: January 2027
• To assess the O-serotype distribution among drug-resistant E. coli, including multidrug resistant (MDR)
Time frame: January 2027
To characterize drug resistance across O-serotypes of E. coli isolates that cause rUTIs in children
Time frame: January 2027
To evaluate the genetic characteristics of E. coli of children with r-UTI (WGS)
Time frame: January 2027
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Giovanni Montini, Prof. study chair
University of Milan
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by PENTA Foundation.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 18 Apr 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To assess the serogroups of E. coli in the study cohort (time frame: January 2027). 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 18 Apr 2025.