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Recruiting NCT07236814

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

Phase III Interventional Influenza

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suraxavir marboxil, Oseltamivir Placebo, Oseltamivir, Suraxavir marboxil placebo.
Who it may be relevant to
Registry conditions: Influenza. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case. [Time frame: within 5 days]
Secondary outcome measures (3)
  • The proportion of room contacts who develop clinical influenza (as defined above) within 10 days [Time frame: within 10 days]
  • The proportion of room contacts with laboratory-confirmed influenza within 5 days [Time frame: Within 5 days]
  • The incidence of post-treatment changes in the influenza virus sequence [Time frame: Within 10 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 2 centers
  • China-Japan Friendship hospital, Beijing, Beijing — Beijing
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07236814 · Sur-Ose-Hospital-Prophylaxis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗