Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case.
研究概览
简要总结
This study aims to evaluate the efficacy of antiviral prophylaxis in preventing in-hospital influenza transmission. We will enroll hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts). These room contacts will be randomized in a 1:1:1 ratio to one of three prophylactic groups: placebo, suraxavir marboxil, or oseltamivir. The primary outcome will be the rate of influenza infection among the room contacts, which will be monitored to determine the effectiveness of the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Inclusion Criteria:
- •(1)Inclusion Criteria for Index Cases:
- •① Patients hospitalized at a participating medical institution.
- •The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
- •Age ≥ 2 years.
- •Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid).
- •(2) Inclusion Criteria for Room Contacts:
- •① Patients hospitalized at a participating medical institution.
- •The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
- •③ Age ≥ 12 years.
- •Expected to remain hospitalized for ≥ 72 hours.
- •Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours.
- •⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day
排除标准
- •(1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:
- •Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.
- •Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.
- •Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).
- •Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).
- •History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.
- •Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Oseltamivir Arm
All subjects will be randomized to receive suraxavir marboxil placebo (40mg on the first day) and oseltamivir (75mg each day during the first five days).
干预措施: Oseltamivir (Drug)
Oseltamivir Arm
All subjects will be randomized to receive suraxavir marboxil placebo (40mg on the first day) and oseltamivir (75mg each day during the first five days).
干预措施: Suraxavir marboxil placebo (Drug)
suraxavir marboxil
All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil (40mg on the first day).
干预措施: Suraxavir marboxil (Drug)
suraxavir marboxil
All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil (40mg on the first day).
干预措施: Oseltamivir (Drug)
Control Arm
All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil placebo (40mg on the first day).
干预措施: Oseltamivir Placebo (Drug)
Control Arm
All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil placebo (40mg on the first day).
干预措施: Suraxavir marboxil placebo (Drug)
结局指标
主要结局
The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case.
时间窗: within 5 days
The proportion of room contacts who develop clinical influenza\* within 5 days, with a virus subtype consistent with that of the index case. \*Clinical influenza is defined as a positive influenza virus detection by Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT), accompanied by at least one respiratory symptom (fever or chills, muscle or joint pain, headache, fatigue) and at least onesystemic symptom (cough, nasal congestion, sore throat).
次要结局
- The proportion of room contacts who develop clinical influenza (as defined above) within 10 days(within 10 days)
- The proportion of room contacts with laboratory-confirmed influenza within 5 days(Within 5 days)
- The incidence of post-treatment changes in the influenza virus sequence(Within 10 days)
研究者
Bin Cao
Professor
Capital Medical University