Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urina… (NCT06482151) | Clinical Trial Compass
WithdrawnNot Applicable
Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection
Stopped: Study terminated by the Funder
0Started 2025-03-11
Plain-language 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
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
To assess the serogroups of E. coli in the study cohort