An observational study in Urinary Tract Infections, sponsored by PENTA Foundation. Withdrawn. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by PENTA Foundation · Observational
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
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).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
Browse Infections studies →PENTA Foundation is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: January 2027
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.
Time frame: January 2027
• To assess the O-serotype distribution among drug-resistant E. coli, including multidrug resistant (MDR)
The number and percent (N \[%\]) of each O-serotype resistant to 0, 1, 2, 3, 4, and 5 antibiotic classes will be assessed. Antimicrobial susceptibility testing will use broth microdilution. Antibiotic panels will include antibiotics from 5 antimicrobial drug classes. Antibiotic resistance will be determined using minimal inhibitory concentration values and susceptibility criteria defined by either the Clinical and Laboratory Standards Institute (CLSI) or the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Time frame: January 2027
To characterize drug resistance across O-serotypes of E. coli isolates that cause rUTIs in children
The resistance to representative antibiotics in the following 5 classes: aminoglycosides, cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, and sulfonamides will be reported. Based on these 5 classes (and representative antibiotics), the multidrug-resistant will be defined as isolates that were resistant to ≥3 of the 5 antibiotic classes listed. Resistance to last-resort antibiotics, carbapenems (doripenem, ertapenem, imipenem, and meropenem) and colistin will also be examined using Clinical and Laboratory Standards Institute breakpoints for minimum inhibitory concentration values.
Time frame: January 2027
To evaluate the genetic characteristics of E. coli of children with r-UTI (WGS)
O genotyping will be conducted based on whole-genome sequencing, which will allow assessment of O-serotype at the genetic sequences level, following guidelines and using reference sequences described elsewhere (DebRoy et all 2016) . For isolates that either do not show a match or match with multiple known O serotypes, the O genotype will be designated as "non-determined." (Iguchi et al, 2014 ) All the evaluations will be performed overall and across countries and age categorizations. Moreover, the Kappa of Cohen will be used to assess the degree of agreement of the results between local laboratories and Central laboratory.
Time frame: January 2027
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
PENTA Foundation