Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection
NCT Number: NCT06482151
Acronym: rUTI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Urinary Tract Infections
Sponsor: PENTA Foundation
Sex: ALL
Age: CHILD
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01
Completion Date: 2027-01

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

Primary Outcome Measures: 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., January 2027
Secondary Outcome Measures: 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., 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)., 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., 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., January 2027