Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
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.
• (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 1.