Influenza
Conditions
Keywords
influenza, suraxavir marboxil, oseltamivir
Brief summary
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
Suraxavir marboxil (40mg on the first day)
Oseltamivir placebo(75mg each day during the first five days)
DRUGOseltamivir
Oseltamivir (75mg each day during the first five days)
DRUGSuraxavir marboxil placebo
Suraxavir marboxil placebo (40mg on the first day).
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of room contacts who develop clinical influenza (as defined above) within 10 days | within 10 days | The proportion of room contacts who develop clinical influenza (as defined above) within 10 days, with a virus subtype consistent with that of the index case. |
| The proportion of room contacts with laboratory-confirmed influenza within 5 days | Within 5 days | The proportion of room contacts with laboratory-confirmed influenza (defined as a positive influenza virus RAT or NAAT result, regardless of symptoms) within 5 days, with a virus subtype consistent with that of the index case. |
| The incidence of post-treatment changes in the influenza virus sequence | Within 10 days | Among room contacts who become infected with influenza virus within 10 days, the incidence of post-treatment changes in the influenza virus sequence (based on viral sequence analysis). This includes the incidence of events such as the I38T amino acid substitution, the H275Y amino acid substitution, and other emerging amino acid substitutions in the PA and NA sequences. |
Countries
China
Contacts
CONTACTYeming Wang, Ph.D.
Outcome results
None listed