NCT00809328已完成3 期
A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Response Rate (Clinical Response, Data Review Committee Assessment)
研究概览
简要总结
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
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 80 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 with CAP.
- •Patients who were diagnosed as moderate in severity.
排除标准
- •Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- •Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
- •Severe renal dysfunction (creatinine clearance < 30 ml/min).
- •Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
- •Severe underlying disease.
研究组 & 干预措施
Azithromycin
Experimental
Azithromycin switch therapy (switch from intravenous to oral)
干预措施: Azithromycin (Drug)
结局指标
主要结局
Response Rate (Clinical Response, Data Review Committee Assessment)
时间窗: End of Treatment, Day 15 and Day 29
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, Day 15 and Day 29)
- The Tendency Toward Clinical Improvement (Investigator Assessment)(Day 3)
- Eradication Rate (Bacteriological Response, Data Review Committee Assessment)(Day 3, End of Treatment, Day 15 and Day 29)
- Eradication Rate (Bacteriological Response, Investigator Assessment)(Day 3, End of Treatment, Day 15 and Day 29)
研究者
研究点 (1)
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