Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 590
- 试验地点
- 24
- 主要终点
- First and second lines used antibiotic therapies
研究概览
简要总结
Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal treatment of E-ESBL is nearly impossible at this time.
Our aim was to describe the characteristics and treatments of urinary tract infections caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.
详细描述
In this prospective observational study between March 2013 and March 2017, children (0 to 18 years) with ESBL-E UTI were enrolled in 24 pediatric departments in France. Clinical and biological characteristics, risk factors of infection of E-ESBL, first and second lines of antibiotic therapies were analyzed. The investigators used the Kaplan-Meier method to estimate the time to fever defervescence and hospitalization duration, and Log-rank test to assess equality of survivor functions. The investigators also analyzed the resistance patterns and molecular characterization of ESBL types in the isolates.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inpatient or outpatient under 18 years with UTI (cystitis or febrile UTI)
- •Clinical signs associated with a positive E-ESBL in urine culture dependent urine collection method as previously described (Stein R, EAU/ESPU guidelines) and an antibiotic treatment targeting this strain.
排除标准
- •Refusal to participate in the study
- •Children with mixed microbial strains and repeated infections were excluded
结局指标
主要结局
First and second lines used antibiotic therapies
时间窗: at inclusion, at 3 days
次要结局
- Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children(at inclusion)
- Resistance patterns of ESBL types in the isolates(at inclusion)
- C reactive protein level of patient with E-ESBL UTI in children(at inclusion)
- Positive blood culture(at inclusion)
- Time to apyrexia (Kaplan-Meier method)(at inclusion)
- Length of hospital stay (Kaplan-Meier method)(at inclusion)
- Molecular characterization of ESBL types in the isolates(at inclusion)
- Clinical history of patient with E-ESBL UTI in children(at inclusion)
- procalcitonin level of patient with E-ESBL UTI in children(at inclusion)
- cytobacteriological examination of the urine results(at inclusion, at 3 days)
- urine analysis by regent strip method(at inclusion)
研究者
Fouad Madhi
Dr
Centre Hospitalier Intercommunal Creteil