This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.
This study will enroll hospitalized patients diagnosed with influenza virus infection (index patients) and their roommates who are not infected with the influenza virus (close contacts). The close contacts will be randomly assigned in a 1:1:1 ratio to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis. The incidence of clinical influenza (confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) testing, along with fever and one respiratory symptom) will be monitored to evaluate the efficiency of antiviral prophylaxis in a hospital setting. The index patients will receive standard treatment for influenza infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
372
Baloxavir marboxil will be administered on the first day following the close contact's enrollment in this study. Participants weighing ≤80 kg will receive 40 mg of baloxavir marboxil, while those weighing ≥80 kg will receive 80 mg.
Oseltamivir will be administered once daily for 5 consecutive days following the close contact's enrollment in this study. Participants will receive 75 mg of oseltamivir once each day.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Incidence of Clinical Influenza within a 5-day period
Incidence of Clinical Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.
Time frame: up to 5 days
Incidence of influenza within a 5-day period
Incidence of Influenza within a 5-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT).
Time frame: up to 5 days
Incidence of Clinical Influenza within a 10-day period
Incidence of Clinical Influenza within a 10-day period is defined as the percentage of contacts who become positive for influenza based on reverse-transcriptase polymerase chain reaction (RT-PCR) testing or rapid antigen testing (RAT), along with fever (defined as axillary temperature ≥37.3℃) and at least one respiratory symptom.
Time frame: up to 10 days
Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation
Susceptibility to antivirals by phenotyping post-baseline samples with novel mutation is defined as the percentage of contacts infected with resistance-associated treatment-emergent influenza variants.
Time frame: up to 10 days
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