Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 13
- 主要终点
- Rate of infection recurrence
研究概览
简要总结
Febrile urinary tract infections (UTIs) are common in children, but there is no consensus concerning the duration of the antibiotic treatment. Current recommendations include the use of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking.
The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children.
The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 3 months to 5 years;
- •Clinical diagnosis of febrile UTI, defined by fever ≥38°C and positive result of urinalysis (nitrite and/or leukocyte esterase positivity) in two consecutive urine samples collected by bladder catheterization or clean catch (19). The diagnosis of UTI will be then confirmed by positive urine culture for a single type of bacterium with a charge> 105 CFU /ml as per the Recommendations of the Italian Society of Pediatric Nephrology (SINePe) (19).
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)
- •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
- •Poor compliance
- •History of jaundice or liver failure positive
研究组 & 干预措施
Short treatment group
Amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 5 consecutive days
干预措施: Amoxicillin and Clavulanic Acid in Oral Dose Form (Drug)
Standard treatment group
amoxicillin and clavulanic acid 50 mg/kg three times daily administered orally for 10 consecutive days
干预措施: Amoxicillin and Clavulanic Acid in Oral Dose Form (Drug)
结局指标
主要结局
Rate of infection recurrence
时间窗: within 30 days after the end of the intervention
Infection recurrence rate is defined as the reappearance of signs and symptoms of febrile UTI by the first day after the end of antibiotic therapy
次要结局
- Rate of complete resolution of signs and symptoms(within 30 days after the end of the intervention)
- Rate of antibiotic-resistant or of opportunistic strains in relapses(within 30 days after the end of the intervention)