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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
384
Suraxavir marboxil (40mg on the first day)
Oseltamivir placebo(75mg each day during the first five days)
Oseltamivir (75mg each day during the first five days)
Suraxavir marboxil placebo (40mg on the first day).
China-Japan Friendship hospital, Beijing, Beijing
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case.
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).
Time frame: within 5 days
The proportion of room contacts who develop clinical influenza (as defined above) 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.
Time frame: within 10 days
The proportion of room contacts with laboratory-confirmed influenza 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.
Time frame: Within 5 days
The incidence of post-treatment changes in the influenza virus sequence
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.
Time frame: Within 10 days
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