A Multicenter, Unblinded, Non-Comparative Study Of Unasyn-S 12 G/Day Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 47
- 试验地点
- 22
- 主要终点
- Response Rate (Clinical Response, Data Review Committee Assessment)
研究概览
简要总结
Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years of age or older.
- •Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.
排除标准
- •Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
- •Hepatic dysfunction [Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin > 3 times upper limit of normal range values].
- •Severe renal dysfunction (creatinine clearance < 30 ml/min).
- •Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
研究组 & 干预措施
ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
干预措施: ampicillin sodium/sulbactam sodium (Drug)
结局指标
主要结局
Response Rate (Clinical Response, Data Review Committee Assessment)
时间窗: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
次要结局
- Response Rate (Clinical Response, Investigator Assessment)(End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure))
- The Tendency Toward Clinical Improvement (Investigator Assessment)(Day 4)
- Eradication Rate (Bacteriological Response, Data Review Committee Assessment)(Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure))
- Eradication Rate (Bacteriological Response, Investigator Assessment)(Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure))