Children (aged 5 to 11) with acute uncomplicated influenza A and B
Conditions
Interventions
Tset group:Masurashave
Sponsors
Nanjing Children's Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. Age between 5 and 11 years old (including the boundary value), gender not limited; 3. Influenza virus infection was confirmed by the following criteria: Confirmed as influenza virus infection by the following criteria: A positive result is diagnosed by a rapid antigen test (RAT) for influenza using a throat swab or nasal swab (rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable). And at the time of screening, there was a fever (axillary temperature >=38?), and at least one moderate or more severe systemic symptom and respiratory symptom; 4. The interval between the onset of symptoms and the first medication is no more than 48 hours; 5. Weight >=15kg; 6. Subjects who are considered by the researcher to be able to take Suraxavir Marboxil tablets; 7. The researcher believes that the subjects and/or their caregivers can comply with the protocol requirements for follow-up and complete all research procedures and evaluations, including filling out diary cards;
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the active ingredients or excipients of the investigational drug; 2. Confirmed as severe or critical cases of influenza during screening: (1) Influenza cases that present with one or more of the following conditions are classified as severe influenza cases: a. Dyspnea and/or increased respiratory rate: >30 breaths per minute for children over 5 years old, >40 breaths per minute for children aged 2 to 5 years old; b. Changes in consciousness: slow response, drowsiness, restlessness, convulsions, etc. c. Severe vomiting and diarrhea, with moderate to severe dehydration manifestations; d. Combined with pneumonia; (2) Any of the following conditions will be classified as a critical case: A. Respiratory failure; b. Acute necrotizing encephalopathy; c. Septic shock; d. Multiple organ dysfunction; e. Other serious clinical conditions that require monitoring and treatment occur; 3. Patients with other concurrent infections who require systemic antibacterial treatment or other systemic therapies; 4. It is known that there is any history of gastrointestinal diseases that affect drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, after subtotal gastrectomy, etc.); 5. The researcher suspects or chest imaging examinations confirm bronchitis, pleural effusion or interstitial pneumonia (whether to conduct imaging examinations is determined by the researcher's assessment); 6. Those who have used anti-influenza virus drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 channel blockers, etc., such as oseltamivir phosphate, zanamivir, peramivir, favipiravir, arbidol, marbaloxavir, amantadine or rimantadine, or other anti-influenza virus drugs approved for marketing by the NMPA, etc.) within two weeks prior to screening; 7. Those who have developed acute respiratory tract infections, otitis media or sinusitis within two weeks prior to screening; 8. There is a known or suspected history of active primary or secondary immunodeficiency, including a known history of HIV infection and other severe immunodeficiency hematological diseases, etc. 9. Known or suspected congenital developmental abnormalities of the heart, lungs, etc., and/or combined serious primary diseases of the cardiovascular and cerebrovascular system, liver, kidneys and hematopoietic system, or evidence of active liver disease; 10. Having received clinical research on any investigational drug or device for any indication within 30 days prior to screening; 11. Those who are intolerant to skin puncture during screening, experience fainting at blood or needle, or have poor blood collection vessel conditions; 12. Subjects who are judged by the researcher as unsuitable to participate in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the safety of a single dose of Suraxavir Marboxil tablets in Chinese pediatric patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of influenza virus RNA turning negative after treatment with Masurashave Tablets and Oseltamivir Phosphate Granules in Chinese pediatric patients;time it takes for fever to subside after treatment with Masurashave Tablets and Oseltamivir Phosphate Granules in Chinese pediatric patients;Describing the time it takes for flu symptoms to subside in Chinese pediatric patients treated with Masurashave Tablets and Oseltamivir Phosphate Granules; | — |
Countries
China
Contacts
Public ContactTian Man
Nanjing Children's Hospital
Outcome results
None listed