jRCT2080223343已完成3 期
CS-8958 Phase 3 study in Pediatric Patients < 10 years of age - A open-labeled study of nebulized CS-8958 in the treatment of influenza virus infection -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 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
- Multicenter, open-labeled study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- No limit 至 9age old under（—）
- 性别
- All
入选标准
- •Tested positive for influenza A or B by the rapid diagnostic test
- •Body temperature (axillary) at informed consent >= 38.0 degrees
- •Within 36 hours of the onset of influenza symptoms at informed consent
- •Judged to be able to take a nebulized treatment
排除标准
- •Suspected of having infection by bacteria species and/or other virus (pneumonia, bronchitis, otitis, sinusitis, etc.; including secondary infection) within 1 week before informed consent
- •History of influenza pneumonia
- •Assessed to be ineligible by the investigators, including those with serious complications
结局指标
主要结局
-
safety efficacy confirmatory Time to alleviation of influenza illness
次要结局
未报告次要终点
研究者
研究点 (1)
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