The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
研究概览
简要总结
The purpose of the investigators study is to evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe nontyphoidal Salmonella enterocolitis in children and the excretion of Salmonella in feces.
详细描述
Nontyphoidal salmonellae (NTS) is one of the most important pathogens of gastroenteritis in humans. Although most nontyphoidal Salmonella infections result in self-limited gastroenteritis, invasive infections such as bacteremia, meningitis or extraintestinal infection could also occur. Antimicrobial therapy is not recommended for routine treatment of nontyphoidal salmonellosis and effective antibiotic treatment is essential if NTS infection spreads beyond the intestine such as bacteremia, meningitis or osteomyelitis.
Although some reports revealed that antimicrobial therapy may be beneficial for shortening the clinical courses of severe NTS enterocolitis, most of them were based on clinical observations, not based on the results of objective examinations. Thus, the use of antibiotics in the treatment of patients with severe NTS gastroenteritis is still controversial in clinical practice.
As a third generation cephalosporin, ceftriaxone has a higher concentration than conventional antibiotics such as ampicillin and trimethoprim-sulfamethoxazole in the intestinal mucosa and gallbladder. Besides, ceftriaxone maintains relatively lower resistance rate in Salmonella than those of other conventional antibiotics. So the purpose of our study is to evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces. The investigators think that the study may be helpful for clinicians in the treatment of severe NTS enterocolitis in children, especially on the judgments of the choices and the treatment cures of antibiotics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with suspected severe Salmonella enterocolitis
- •defined as those with a high fever (core body temperature ≥ 38.5℃) persisting for longer than 48 hours
- •diarrhea with mucous and bloody-tinged stool.
排除标准
- •Children with a toxic appearance, severe vomiting and abdominal distension
- •suggestive of sepsis or toxic megacolon, those with an increased risk of invasive NTS diseases
- •immunosuppressive illnesses
- •had taken antibiotics during the 7 days before the visit will be excluded.
研究组 & 干预措施
ceftriaxone
干预措施: ceftriaxone (Drug)
结局指标
主要结局
To evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
时间窗: Three months
Patients will be separated into 2 groups. One is treated with parenteral ceftriaxone and the other is treated with supportive drugs. Then we evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
次要结局
- PCR detection will be used for Salmonella in stool samples.(Three month)
