Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06482151
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT06482151
Study Brief:
Protocol Section:
NCT06482151