JPRN-jRCT2080222627已完成3 期
A Phase 3 Study of CS-8958 (Prophylaxis for children) - A randomized, double-blind, placebo-controlled study to evaluate the efficacy for the prevention of influenza virus infection in children under 10 years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 343
研究概览
简要总结
Single 20-mg dose of inhaled CS-8958 20 mg was effective as post-exposure prophylaxis to protect against influenza in pediatric (<10 years of age) household members of index cases for prophylaxis of influenza. Adverse events in CS-8958 20 mg single-dose group did not differ significantly from those in the placebo-group. No abnormal behaviors were observed, and there were no other major safety issues.
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
- •Household contact of a patient with influenza virus infection
- •Body temperature (axillary) at informed consent =< 36.9 degrees C
- •No influenza symptoms
- •Be capable of inhaling drug judged by investigator
排除标准
- •Persons who are unable to cohabit with an index patient
- •Persons who cannot start study treatment within 48 hours after the initial onset of any influenza symptom in the index patient
- •Persons receiving corticosteroids or immunosuppressants
- •Persons who have a history of hypersensitivity to a neuraminidase inhibitor
研究者
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