jRCT2080222672未知2 期
A Phase II, multi-center, randomized, double-blind study of T-4288 in patients with community-acquired pneumonia
Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)0 个研究点开始时间: 待定
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multi-center, Randomized, Double-Blind, Active-controlled study
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age: 20 years of age and older
- •Gender : Both
- •Confirmed clear infiltrative shadow by chest X-ray or CT within 48 hours prior to the first administration of the study drug
- •Confirmed at least one of the following changes in laboratory values;
- •WBC increased (WBC > 10000 /mm3)
- •Stab cell > 15%
- •WBC decreased (WBC < 4500 /mm3)
- •Confirmed at least one of the following clinical symptoms and/or findings:
- •Abnormal findings on auscultation and/or percussion
- •Dyspnea or tachypnea
排除标准
- •Having improvement of clinical symptoms due to pneumonia by other systemic antibiotics
- •Having a history of allergy to macrolide or quinolone antibiotics
结局指标
主要结局
-
efficacy, safety and pharmacokinetic profile
次要结局
未报告次要终点
研究者
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