A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,138
- 试验地点
- 138
- 主要终点
- Percentage of HHCs With Virological Influenza Transmission by Day 5
研究概览
简要总结
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Baloxavir Marboxil
Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
干预措施: Baloxavir Marboxil (Drug)
Placebo
Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of HHCs With Virological Influenza Transmission by Day 5
时间窗: Baseline (Day 1) to Day 5
The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimating equations (GEE) approach.
次要结局
- Percentage of HHCs With Symptomatic Influenza Transmission by Day 5(Baseline (Day 1) to Day 5)
- Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5(Baseline (Day 1) to Day 5)
- Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5(Baseline (Day 1) to Day 5)
- Percentage of HHCs With Virological Influenza Transmission by Day 9(Baseline (Day 1) to Day 9)
- Percentage of HHCs With Symptomatic Influenza Transmission by Day 9(Baseline (Day 1) to Day 9)
- Percentage of HHCs With Any Virological Infection by Day 9(Baseline (Day 1) to Day 9)
- Percentage of HHs With Any Virological Infection at HH Level by Day 9(Baseline (Day 1) to Day 9)
- Percentage of HHCs With Any Symptomatic Infection by Day 9(Baseline (Day 1) to Day 9)
- Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9(Baseline (Day 1) to Day 9)
- Number of IPs With Adverse Events (AEs)(Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old))
- Number of IPs With Serious Adverse Events (SAEs)(Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old))