Evaluation of the Prevalence of E. Coli O Serotypes in Pa... | NCT06482151

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

NCT06482151

Sponsor

PENTA Foundation

Status

Withdrawn

Last Update Posted

Apr 18, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Urinary Tract Infections

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated by the Funder

Expanded Access Info

Start Date

Mar 11, 2025Actual

Primary Completion Date

Mar 11, 2025Actual

Completion Date

Mar 11, 2025Actual

First Submitted Date

Jun 25, 2024

First Submission Date that Met QC Criteria

Jun 25, 2024

First Posted Date

Jul 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2025

Last Update Posted Date

Apr 18, 2025Actual

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Giovanni Montini, Prof.	University of Milan	Study Chair

ID	Term
D014552	Urinary Tract Infections
D004927	Escherichia coli Infections

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Description

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.