7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 221
- 试验地点
- 4
- 主要终点
- frequencies of recurrence of UTI
研究概览
简要总结
The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance.
详细描述
In previously published European and global guidelines, there has been no consensus among experts regarding the duration of therapy for a febrile UTI. Depending on the recommendation, the duration of treatment should be between 7-14 days.
221 patients aged 3 months to 7 years with febrile UTIs (defined as a combination of fever and leukocyturia in urine sediment) will be randomly assigned to receive a 7-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded cefuroxime axetil).
The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention. The secondary outcome measures will be antibiotic-associated diarrhea and compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(must have all):
- •children aged from 3 months to 7 years
- •clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment >10 in the field of view);
- •fever ≥38°C
- •positive urine collection with sensitivity for cefuroxime
- •treatment cefuroxime or cefuroxime axetil for 7 days
排除标准
- •(must have one):
- •history of a UTI in the last 3 months
- •prophylaxis for UTI
- •antibiotic therapy in the last month
- •known allergy to the study drugs
- •immunosuppression therapy
- •disease with immune deficiency
- •children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
- •severe obstructive uropathy
研究组 & 干预措施
Antibiotic therapy for 10 days
After 7 days of cefuroxime treatment (oral, intravenous or sequential), patients from day 8 to day 10 will continue to receive the antibiotic (in blinded bottle).
干预措施: Longer therapy duration (Other)
Antibiotic therapy for 7 days
After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle).
干预措施: Shorter therapy duration (Other)
结局指标
主要结局
frequencies of recurrence of UTI
时间窗: 3 months after intervention
New onset of symptomatic UTI within the 3 months follow-up period. The recurrence of a UTI is diagnosed when the next infection is caused by the same microorganism during 3 months following the treatment of a UTI.
次要结局
- frequencies of reinfection of UTI(6 months after intervention)
- antibiotic-associated diarrhoea (AAD), compliance(7 days after intervention)