Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting

Обзор

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.

Вмешательства

• Препарат Suraxavir marboxil
  Suraxavir marboxil (40mg on the first day)
• Препарат Oseltamivir Placebo
  Oseltamivir placebo(75mg each day during the first five days)
• Препарат Oseltamivir
  Oseltamivir (75mg each day during the first five days)
• Препарат Suraxavir marboxil placebo
  Suraxavir marboxil placebo (40mg on the first day).

Первичные конечные точки

• The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case. [Срок оценки: within 5 days]

Вторичные конечные точки (3)

• The proportion of room contacts who develop clinical influenza (as defined above) within 10 days [Срок оценки: within 10 days]
• The proportion of room contacts with laboratory-confirmed influenza within 5 days [Срок оценки: Within 5 days]
• The incidence of post-treatment changes in the influenza virus sequence [Срок оценки: Within 10 days]

Критерии участия

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 1.

3.Exclusion Criteria

(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• China-Japan Friendship hospital, Beijing, Beijing — Пекин
• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07236814 · Sur-Ose-Hospital-Prophylaxis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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