Evaluation of the Prevalence of E. Coli O Serotypes in Paediatric Population With Recurrent Urinary Tract Infection in Europe
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 600
- 主要终点
- To assess the serogroups of E. coli in the study cohort
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To assess the serogroups of E. coli in the study cohort
时间窗: January 2027
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.
次要结局
- To assess the clinical profile, especially comorbidities, of children with UTI and rUTI(January 2027)
- • To assess the O-serotype distribution among drug-resistant E. coli, including multidrug resistant (MDR)(January 2027)
- To evaluate the genetic characteristics of E. coli of children with r-UTI (WGS)(January 2027)
- To characterize drug resistance across O-serotypes of E. coli isolates that cause rUTIs in children(January 2027)