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

NCT ID: NCT06482151

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-03-11

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).

Conditions

Urinary Tract Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PENTA Foundation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Montini, Prof.

Role: STUDY_CHAIR

University of Milan

Other Identifiers

rUTI

Identifier Type: -

Identifier Source: org_study_id