Clinical trial NCT06482151: Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection
Official title: Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection in Europe
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urinary Tract Infections
Keywords: urinary tract infections
recurrent urinary tract infections
infants
adolescents
Escherichia coli
Lead sponsor: PENTA Foundation
Sponsor class: NETWORK
First posted: 2024-07-01
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To assess the serogroups of E. coli in the study cohort
timeFrame: January 2027
Secondary outcomes:
measure: To assess the clinical profile, especially comorbidities, of children with UTI and rUTI
timeFrame: January 2027
measure: • To assess the O-serotype distribution among drug-resistant E. coli, including multidrug resistant (MDR)
timeFrame: January 2027
measure: To characterize drug resistance across O-serotypes of E. coli isolates that cause rUTIs in children
timeFrame: January 2027
measure: To evaluate the genetic characteristics of E. coli of children with r-UTI (WGS)
timeFrame: January 2027
Other outcomes:
Locations:
Study officials:
affiliation: University of Milan
name: Giovanni Montini, Prof.
role: STUDY_CHAIR
References: