Inclusion criteria | |
Age 6 to < 12 years | |
Body weight ≥ 10 kg | |
Diagnosed with influenza infection defined as: Fever (axillary temperature ≥ 38 °C) A positive RIDT by nasopharyngeal swab, pharyngeal swab, or nasal discharge At least one moderate or severe respiratory symptom (cough and nasal discharge/nasal congestion) | |
Onset of first confirmed fever (≥ 37.5 °C) no more than 48 h before screening (Day 1) | |
Judged by the investigator as able to take baloxavir tablet(s) and oseltamivir capsules or dry syrup | |
Where possible, written informed assent from children Written informed consent from a parent or legal guardian | |
Parents/guardians willing and able to comply with the trial requirements Patients who can comply with the trial requirements to the level of their understanding | |
Exclusion criteria | |
Severe influenza symptoms requiring hospitalization | |
Risk factors for influenza infection including: Chronic respiratory diseases including uncontrolled bronchial asthma Hepatitis, liver cirrhosis Neurological disorders and neurodevelopmental disorders including brain, spinal, peripheral, and muscle disorders Endocrine disorders including diabetes, thyroid disease, and adrenal gland abnormalities Heart disease requiring drug treatment including congenital heart disease, congestive heart failure, and coronary artery disease | |
Receiving systemic corticosteroids or immunosuppressive therapy | |
Primary immunodeficiency syndrome | |
Severe renal impairment (creatinine clearance < 30 mL/min or eGFR < 30 mL/min/1.73 m2) | |
Human immunodeficiency virus infection | |
Malignant disease within the past 5 years | |
Disorders of consciousness including abnormal behaviora and convulsions, and complicated by encephalitis/encephalopathy | |
History of encephalitis/encephalopathy or epilepsy not controlled with antiepileptic drugs or abnormal behaviora associated with influenza infection in the past 2 years | |
Infectious diseases requiring systemic antimicrobial therapy and/or antiviral medicine (except anti-influenza medicine) at screening | |
Considered by the investigator to be using prohibited drugs | |
Receiving baloxavir, amantadine, or NAIs (oseltamivir, zanamivir, peramivir, and laninamivir) within 30 days before screening | |
History of allergies to anti-influenza drugs, or acetaminophen, or clinically problematic intolerance | |
Positive SARS-CoV-2 or suspected COVID-19 disease | |
Any underlying disease that may affect study outcomes | |
Difficulty collecting blood from a vein Patients received an investigational or unapproved drug within 30 days or 5 half-lives, whichever is longer, before screening Patients with diseases or conditions which, in the opinion of the investigator, may make it difficult to ensure patient safety or study data quality Patients who, in the opinion of the investigator, are inappropriate for participation in the study Female patients who has experienced menarche and who are pregnant, plan to become pregnant during the study period, or are breastfeeding |