NCT04395365进行中（未招募）3 期
Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
A multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival
详细描述
See above
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Co-trimoxazole
Experimental
Co-trimoxazole, 960mg capsule oral tablet, to be taken daily for 18 months
干预措施: Co-Trimoxazole 960Mg Dispersible Tablet (Drug)
Placebo
Placebo Comparator
Placebo, 960mg capsule oral tablet, to be taken daily for 18 months
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Overall Survival
时间窗: The maximum possible period of follow up will be 48 months (assuming a recruitment period of 30 months and 18 months treatment period for final patient recruited)
Overall Survival
次要结局
- Infections other than spontaneous bacterial peritonitis with hospital admission(Minimum period of 18 months from randomisation)
- Spontaneous Bacterial peritonitis(Minimum period of 18 months from randomisation)
- Hospital admissions(Minimum period of 18 months from randomisation)
- C. difficile-associated diarrhoea(Minimum period of 18 months from randomisation)
- Cirrhosis related events(Minimum period of 18 months from randomisation)
- Renal dysfunction(Minimum period of 18 months from randomisation)
- Anti-microbial resistance(Minimum period of 18 months from randomisation)
- Liver transplantation(Minimum period of 18 months from randomisation)
- Liver disease assessed by increase in MELD score(Minimum period of 18 months from randomisation)
- Safety and treatment-related serious adverse events(Minimum period of 18 months from randomisation)
- Treatment adherence(Minimum period of 18 months from randomisation)
- Health-related quality of life(Minimum period of 18 months from randomisation)
- Mean incremental cost per quality adjusted life year gained (QALY)(Minimum period of 18 months from randomisation)
- Health and social care(Minimum period of 18 months from randomisation)
- Incidence of resolution of ascites with diuretic treatment not required for 6 months(Minimum period of 18 months from randomisation)
- Transjugular intrahepatic portosystemic shunt (TIPS) insertion(Minimum period of 18 months from randomisation)
研究者
研究点 (1)
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