Randomised Controlled Trial on Efficacy and Safety of Short Term Versus Long Term Antibiotic Therapy for Pyelonephritis in Childhood.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate of renal SCAR
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of oral ceftibuten for 7 days versus 10 days in acute pyelonephritis in children.
The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10 days in the rate of renal scarring at 6-12 months.
详细描述
Acute pyelonephritis is one of the most common serious bacterial infections in childhood, particularly in young children, with an estimated prevalence in febrile infants of 5.3%. It has been considered an important risk factor for the development of renal scarring, and renal insufficiency. More recently the long term outcomes of pyelonephritis has ameliorated, probably because of prompt diagnosis and therapy, and the importance of urinary tract infection as a risk factor for renal insufficiency has been questioned.
Nevertheless, the optimal type and duration of antibiotic therapy for acute uncomplicated pyelonephritis in children is not established yet.
There is a general agreement that children who are dehydrated, unable to drink, or in whom sepsis is possible, should be admitted to hospital for intravenous antibiotic treatment.
Outside this conditions, evidence suggest that children with acute pyelonephritis can be treated effectively with cefixime, ceftibuten or amoxycillin/clavulanic acid. given orally (1).
A recently updated Cochrane review on antibiotic treatment for acute pyelonephritis in children identified twenty three studies (3407 children). No significant differences were found in persistent renal damage at six to 12 months (824 children: RR 0.80, 95% CI 0.50 to 1.26) or in duration of fever (808 children: WMD 2.05, 95% CI -0.84 to 4.94) between oral antibiotic therapy (10 to 14 days) and IV therapy (3 days) followed by oral therapy (10 days). Similarly no significant differences in persistent renal damage (3 studies, 341 children: RR 1.13, 95% CI 0.86 to 1.49) were found between IV therapy (3 to 4 days) followed by oral therapy and IV therapy for 7 to 14 days.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 month to 5 years, with a first episode of pyelonephritis.
排除标准
- •Children less than 1 month, or older than 5 years.
- •Relapse of pyelonephritis.
- •Sepsis and/or vomiting, or other conditions where it's impossible to administer an oral therapy.
- •Allergy to ceftibuten.
- •Previous antibiotic therapy for the same infection.
- •Long term antibiotic prophylaxis with an antibiotic of the same class, if laboratory antibiotic resistance is shown.
- •Children with uncontrolled other disease.
- •Complicated pyelonephritis (abscess).
研究组 & 干预措施
2
干预措施: ceftibuten (Drug)
1
干预措施: ceftibuten (Drug)
结局指标
主要结局
Rate of renal SCAR
时间窗: 6-12 month from urinary tract infection
次要结局
- Relapses(up to12 months)
- Adverse effects of drug therapy(10 days)
研究者
Marzia Lazzerini
MD
IRCCS Burlo Garofolo
