2025-520622-38-00招募中3 期
Personalized antibiotic TREATment for febrile Urinary Tract Infections in children (TREAT-UTI study): multicenter randomized controlled trial
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo19 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2026年2月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 19
- 主要终点
- Rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI and positive urine culture within 30 days after the end of antibiotic therapy.
研究概览
简要总结
The primary objective is to determine if antibiotic therapy with amoxicillin and clavulanic acid taken for a period of 24 hours after the resolution of fever is non-inferior to the standard 10-day regimen in terms of rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI within 30 days after the end of antibiotic therapy
研究设计
- 分配方式
- Randomized
- 主要目的
- Personalized antibiotic TREATment for febrile Urinary Tract Infections in children (TREAT-UTI study)
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age from 3 months to 3 years
- •Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) on urine samples collected according to Italian Society of Pediatric Nephrology (SINePe) guidelines. The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge >105 CFU/ml (>104 CFU/ml for urine samples collected by bladder catheterization) as per the Recommendations of the SINePe;
- •Informed consent signed by parents
排除标准
- •"Complicated" febrile UTI (septic appearance, repeated vomiting impeding oral administration of the antibiotic, severe-moderate dehydration with the need for intravenous antibiotic therapy);
- •Poor compliance;
- •History of jaundice or liver failure.
- •Presence of an inserted urinary catheter;
- •Immunodeficiency;
- •Hypersensitivity to the active substance or other beta-lactam antibiotics;
- •Any antibiotic treatment received in the previous 15 days;
- •Presence of another poorly controlled chronic medical condition (diabetes, inflammatory bowel disease, etc.);
- •Presence of neurological bladder;
- •Presence of phenylketonuria or glucose-galactose malabsorption;
- •Intestinal malabsorption;
结局指标
主要结局
Rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI and positive urine culture within 30 days after the end of antibiotic therapy.
Rate of infection recurrence, defined as the reappearance of signs and symptoms of febrile UTI and positive urine culture within 30 days after the end of antibiotic therapy.
次要结局
- 1. Short-term clinical efficacy between the two groups will be evaluated by clinical assessment and urinalysis during the follow-up.
- 2. The rate of emergence of antibiotic-resistance or opportunistic strains, defined as the presence of positive urinalysis and positive urine culture for a single type of bacterium resistant to amoxicillin and clavulanic acid, after treatment in case of relapse. It will only be evaluated in suspected relapses by carrying out a urine test and urine culture. The bacterial growth will be considered significant if >105 CF/ml (>104 CFU/ml for urine samples collected by bladder catheterization)
研究者
Prof. E. Barbi
Scientific
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
研究点 (19)
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