A Multi-centre, Non-inferiority, Randomized, Double-blind, Phase IV Study Comparing Pristinamycin (2g x 2 Per Day for 2 Days Then 1g x 3 Per Day for 5 to 7 Days) to Amoxicillin (1g x 3 Per Day) for 7 to 9 Days in Adults With Acute Community Acquired Pneumonia With a PORT Score of II or III
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 161
- 试验地点
- 19
- 主要终点
- Percentage of patients cured established from the clinical course and pulmonary radiological course
研究概览
简要总结
Primary Objective:
To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment.
Secondary Objectives:
To evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level.
To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse and mortality 30±2 days after treatment is started.
To document failures. To collect and follow up adverse events.
详细描述
The total study duration for each patient is 1 month with a treatment period of 7 to 9 days and a follow-up period of 21 to 23 days.
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
- Double
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
Pristinamycin + Placebo
Pristinamycin: 500 mg tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days Amoxicillin Placebo: capsule, 2 capsules x 3 /day for 7 to 9 days.
干预措施: PRISTINAMYCIN XRP7263 (Drug)
Pristinamycin + Placebo
Pristinamycin: 500 mg tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days Amoxicillin Placebo: capsule, 2 capsules x 3 /day for 7 to 9 days.
干预措施: Amoxicillin Placebo (Drug)
Amoxicillin + Placebo
Amoxicillin: 500 mg capsule, 2 capsules x 3/day for 7 to 9 days Pristinamycin Placebo: tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days.
干预措施: Amoxicillin (Drug)
Amoxicillin + Placebo
Amoxicillin: 500 mg capsule, 2 capsules x 3/day for 7 to 9 days Pristinamycin Placebo: tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days.
干预措施: PRISTINAMYCIN Placebo (Drug)
结局指标
主要结局
Percentage of patients cured established from the clinical course and pulmonary radiological course
时间窗: 5 to 9 days post-treatment
次要结局
- Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels(5 to 9 days post-treatment)
- Percentage of cured patients evaluated by bacteriological documentation for pneumococcus(5 to 9 days post-treatment)
- Percentage of patients with relapse(at Day 30)
- Proportion of patients with adverse events(up to Day 30)
- Mortality rate(at Day 30)
- Number of documented failures(5 to 9 days post-treatment)