Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old. Cefixime PO 10d vs Ceftriaxone IV 4d Followed by Cefixime PO 6d. Multicenter, Randomised Trial of Equivalence.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 12
- 主要终点
- Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
研究概览
简要总结
The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.
The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.
详细描述
Guidelines for treatment of acute pyelonephritis in infants and children are different from one country to another. The main question is the incidence of renal scars.
intravenous route (IV) treatment is supposed to give the best results, but no previous study has ever given the incidence of renal scars after PO treatment.
This multicenter, randomised trial is an equivalence study of PO and intravenous route (IV) treatments.
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
- None
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children more than 1 month old and less than 3 years old
- •First episode of acute pyelonephritis with gram negative strains
- •Fever more than 38.5°C
- •Procalcitonin (PCT) value > 0.5 ng/ml
- •Urine obtained by transurethral bladder catheterization, suprapubic aspiration or midstream collection
- •Urine exam: more than 100.000 leukocytes and gram negative strains +
- •Normal hemodynamic exam
- •Normal renal ultrasonography
- •Positive DMSA renal scan for pyelonephritis during the first week after diagnosis
- •Parental informed consent
排除标准
- •Children more than 3 years old
- •Past urine infection
- •Septic hemodynamic abnormalities
- •Obstructive uropathy and any renal ultrasonography abnormalities
- •Allergy to cefixime or ceftriaxone
- •Antibiotic during the five previous days
- •Gastrointestinal abnormalities able to interfere with antibiotic intake or absorption
- •Absence of parental consent
- •Social familial difficulties
研究组 & 干预措施
1
cefixime antibiotic treatment by oral route
干预措施: antibiotic (Drug)
2
ceftriaxone antibiotic treatment by venous infusion and cefixime antibiotic treatment by oral route during six days
干预措施: antibiotics (Drug)
结局指标
主要结局
Renal scars on dimercaptosuccinic acid (DMSA) renal scan at 6 months
时间窗: between six and eight months
次要结局
- Time to get apyrexia(4 days)
- Incidence of urologic abnormalities on cystourethrography done during the first month after the infection(one month)