Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection

NCT06482151 | Withdrawn

• 1 other identifier: rUTI
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urinary Tract Infections

Keywords

urinary tract infections; recurrent urinary tract infections; infants; adolescents; Escherichia coli

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To assess the clinical profile, especially comorbidities, of children with UTI and rUTI

  January 2027

• • To assess the O-serotype distribution among drug-resistant E. coli, including multidrug resistant (MDR)

  January 2027

• To characterize drug resistance across O-serotypes of E. coli isolates that cause rUTIs in children

  January 2027

• To evaluate the genetic characteristics of E. coli of children with r-UTI (WGS)

  January 2027

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PENTA Foundation: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples will be collected in case of a diagnosis of UTI/rUTI. These samples will be used for the isolation of bacteria. E. coli isolates will be subjected to antimicrobial resistance testing and whole genome sequencing by Illumina short-read sequencing with a minimum sequencing depth of 50X to determine genotype O, multi-locus sequence type and the presence of virulence and resistance genes.

MeSH Terms

Conditions

Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Giovanni Montini, Prof.

  University of Milan

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: March 11, 2025
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share