Assessment of the Efficacy on the 5th Day of Antibiotic Therapy for Febrile Urinary Tract Infections Among Children From 3 Months to 18 Years Old
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 主要终点
- Effectiveness of treatment
研究概览
简要总结
The main objective is to describe the rate of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection in children between 3 months and 18 years of age.
详细描述
This is a non-randomised prospective monocentric pilot study whose main objective is to describe the proportion of asymptomatic patients after 5 days of effective antibiotic therapy in an uncomplicated febrile urinary tract infection, in children between 3 months and 18 years of age. After being informed about the study, all patient meeting inclusion criteria will respond to a survey at D2, D5, D10 and D28 to evaluate the persistence of symptoms to determine the effectiveness of a 5-day course of antibiotic treatment. All patients will be treated in accordance to the French guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child between 3 months and 18 years old
- •Diagnosis of uncomplicated febrile urinary tract infection certain and defined by :
- •Naked fever (without an identifiable source of infection) for at least 24 hours for boys and 48 hours for girls.
- •A urine test strip with at least 2 crosses of leukocyturia ≥ or 1 cross of leukocyturia ≥ with positive nitrituria
- •A cytobacteriological urine test with leukocyturia greater than 10/mm3 in the case of catheterisation or Clean catch or greater than 100/mm3 if the collection is performed by bag (Urinocol®).
- •Positive bacteriological urine culture
- •Response to antibiotic therapy
- •Absence of other diagnoses that could explain the clinical picture
排除标准
- •Children under 3 months old
- •Immunodepression
- •Underlying uropathy or known neurological bladder disease
研究组 & 干预措施
Patient having urinary tract infection
Patients with a confirmed urinary tract infection in accordance with the GPIP (french Pediatric Infectious Disease Group) definition and inclusion criteria.
干预措施: Survey (Other)
结局指标
主要结局
Effectiveness of treatment
时间窗: Day 5
The main evaluation criteria aims to determine the effectiveness of a 5-day course of antibiotic treatment. Treatment failure is characterised by the presence at Day 5 of clinical signs (abdominal pain, urinary functional signs, urinary burns) and/or a fever ≥ at 38°C and/or a new positive cytobacteriological urine test performed after antibiotic therapy due to the persistence and/or reappearance of symptoms.
次要结局
- Leukocyte count(Day 1)
- Mode of sampling(Day 1)
- Rate of failure(Day 28)
- Procalcitonin levels(Day 1)
- CRP levels(Day 1)
- Polynuclear cell count(Day 1)