This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to \<12 Years) with Uncomplicated Influenza.
Male or female participants aged 2 to 12 years (≥2 years and <12 years).
body weight≥10 kg at screening.
Positive rapid antigen test (RAT) result from a throat or nasal swab for influenza virus (rapid nucleic acid tests or other rapid molecular diagnostic tests are also acceptable); and
Fever at screening (tympanic temperature ≥38.0°C or axillary temperature ≥37.5°C). If antipyretics were taken, fever must be present >1 hour after administration, or If fever subsided (tympanic <38.0°C or axillary <37.5°C) after antipyretic use, fever must have recurred >4 hours after administration; and
Known hypersensitivity to the active ingredient or excipients of the investigational product.
Patients diagnosed with severe or critical influenza at screening: (1) Severe influenza cases were defined by the presence of one or more of the following conditions: a. Dyspnea and/or tachypnea without fever: >30 breaths/min (age >5 years), >40 breaths/min (age 2-5 years).b. Altered mental status (e.g., lethargy, agitation, seizures).c. Severe vomiting/diarrhea with moderate-to-severe dehydration.d. Concurrent pneumonia.e. Significant exacerbation of pre-existing comorbidities.(2) Critical influenza cases were defined by the presence of one or more of the following conditions: a. Respiratory failure.b. Acute necrotizing encephalopathy.c. Septic shock.d. Multiorgan dysfunction.e. Other life-threatening conditions requiring intensive care.
History of gastrointestinal diseases affecting drug absorption (e.g., reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-gastrectomy).
Bronchitis, pleural effusion, or interstitial pneumonia suspected by investigator or confirmed by chest imaging.
Parallel
Suraxavir Marboxil
DrugSuraxavir Marboxil will be administered as oral suspension: 40 mg (if weight ≥ 32 kg), or 20 mg (if weight \<32 kg).
Oseltamivir
DrugOseltamivir will be administered as oral granules: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≤ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time to Alleviation of Symptoms (TTAS)
Defined as the time from treatment initiation until meeting all criteria below for ≥21.5 consecutive hours: 1. Return to afebrile status (tympanic temperature ≤37.2°C); 2. Absence/Mild severity for all respiratory symptoms (cough, nasal congestion, rhinorrhea) on the Canadian Acute Respiratory Illness and Flu Scale (CARIFS); 3. "Yes" response to: "Has your child resumed normal daily activities as before illness?" in the Daily Activity Questionnaire.
Time to Viral Clearance
Time from treatment initiation until first undetectable viral titer (below the lower limit of quantification, LLOQ).
Viral Clearance Rate
Proportion of participants with viral titers below LLOQ at D2, D3 (if applicable), and D6 (if applicable).
Proportion of patients with influenza viral RNA positivity (by Q-PCR) and measurable viral titers at each time point(D2, D3 if applicable, D6 if applicable).
The percentage of patients positive for virus RNA by Q-PCR. Virus titer was quantified from nasopharyngeal swabs by tissue culture methods.
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