A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases In Japan Adults

Pfizer20 个研究点分布在 1 个国家目标入组 64 人开始时间: 2006年10月最近更新: 2011年4月21日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 64
试验地点: 20
主要终点: The primary endpoint is investigator's clinical efficacy at Day 8.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR formulation.

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

•Patients who were diagnosed as mild or moderate in severity by the classification of infection of the Japanese Society of Chemotherapy guidelines for the evaluation methods of new antibacterial drug (established in 1997).

排除标准

•Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

结局指标

主要结局

The primary endpoint is investigator's clinical efficacy at Day 8.

次要结局

Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 15 and 29), and the tendency toward clinical improvement (at Day 4); Bacteriological efficacy (at Day 4, 8, 15 and 29); Safety Endpoints: Adverse events and safety lab data.

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (20)

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