NCT04161768招募中3 期
Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of bouts of recurrence during treatment.
研究概览
简要总结
Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
详细描述
Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cirrhotic patients with ascites who had previous episodes of SBP.
排除标准
- •Allergy or contraindication for the used drugs.
- •Recent antibiotics therapy in the previous 2 weeks.
- •Patients with hepatocellular carcinoma or other neoplasia.
- •Pregnant and lactating women.
研究组 & 干预措施
Norfloxacin
Active Comparator
Norfloxacin 400 mg daily
干预措施: Norfloxacin (Drug)
Norfloxacin and Itopride
Experimental
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
干预措施: Norfloxacin (Drug)
Norfloxacin and Itopride
Experimental
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
干预措施: Itopride (Drug)
结局指标
主要结局
Number of bouts of recurrence during treatment.
时间窗: 6 months
The recurrence of infection during treatment.
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Ass. Prof. Tropical Medicine
Tanta University
研究点 (1)
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