JPRN-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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
研究概览
简要总结
CS-8958 nebulizer inhaler 160 mg was confirmed to have some efficacy in children younger than 10 years with influenza A or B virus infection. There were no notable safety concerns associated with a single inhaled dose of CS-8958 nebulizer 160 mg.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 9age old（—）
- 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
研究者
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