Positive for influenza A/B
Conditions
Interventions
Test group:Oral dose of baloxavir marboxil for suspension
Sponsors
Beijing Childrens Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1.Signed Informed Consent Form (ICF):A parent or authorized adult will be required to sign the ICF on behalf of the pediatric participant. The informed consent/assent of voluntary participation should be obtained in accordance with local requirements; 2.Age 1 to < 5 years at the time of signing ICF; 3.A participant who has a diagnosis of influenza virus infection and meets all the following conditions.:Fever = 38°C (tympanic temperature) at screening ;At least one of the respiratory symptoms of influenza virus infection (e.g., cough and nasal discharge/nasal congestion);A rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) shows positive for influenza A/B, e.g., with use of nasal swab based on Cobas® influenza A/B Assay, or other point-of-care/local laboratory results with use of nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample) Results from local testing as part of standard of care are acceptable if samples are collected within 24 hours of screening and recorded in the participants’ medical records. 4.The time interval between the onset of symptoms and screening is <= 48 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5°C if known, or the time when the first symptom was noticed by participant, parent, or caregiver); 5.A participant who will be able to take baloxavir marboxil granules for oral suspension in the opinion of the investigator/sub-investigator; 6.A participant whose parent/guardian is willing and able to adhere to the study requirements in the opinion of the investigator/sub-investigator; 7.A participant who is able to adhere to the study requirements appropriately for the level of understanding;
Exclusion criteria
Exclusion criteria: 1.A participant having severe influenza virus infection symptoms requiring inpatient treatment; 2.Severe renal impairment (equivalent to CLCr < 30 mL/min or estimated glomerular filtration rate < 30 mL/min/1.73 m2 ), vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), uncontrolled hepatitis, cirrhosis, or pulmonary disease (e.g. uncontrolled bronchial asthma); 3.Received systemic corticosteroid or immunosuppressive therapy; 4.Primary immunodeficiency syndrome; 5.History of organ transplantation; 6.HIV infection; 7.Immunization with a live/attenuated influenza vaccine in 2 weeks prior to randomization; 8.Previous malignancy within the last 5 years or has an active cancer at any site; 9.Previous encephalitis/encephalopathy, uncontrolled epilepsy with antiepileptic drugs, or influenza virus infection-associated abnormal behavior within the last 2 years; 10.Complications by an infection requiring systemic antibiotic drug, antifungal and/or antiviral drug at screening; 11.Use of prohibited concomitant drugs while in the study in the opinion of the investigator; 12.A participant who received any medications with anti-flu effect such as baloxavir marboxil, peramivir, oseltamivir, zanamivir, favipiravir, arbidol, amantadine or Chinese patent medicines with anti-influenza virus components within 30 days before screening; 13.Known allergy and/or clinically problematic intolerance to baloxavir marboxil and/or acetaminophen and ibuprofen. 14.Severe underlying disease or condition potentially affecting study evaluation in the opinion of the investigator/sub-investigator; 15.A participant who received an investigational or unapproved drug product within 30 days or 5 ×the half-life before screening, whichever is longer;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in vital sign measurements.;Incidence, severity, and timing of adverse events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to alleviation of influenza signs and symptoms.;Duration of fever;Duration of symptoms;Time to return to normal health and activity.;Incidence of influenza-related complications (death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis);Proportion of participants requiring antibiotics for influenza related complications.;Time to cessation of viral shedding by RT-PCR with use of samples from respiratory swabs.;Change from baseline in the amount of virus RNA (RT-PCR) at each timepoint with use of samples from respiratory swabs.;Proportion of participants positive by RT-PCR at each timepoint with use of samples from respiratory swabs.;Area under the curve in virus titer and in the amount of virus RNA (RT-PCR) with use of samples from respiratory swabs.; | — |
Countries
China
Contacts
Public ContactZhao Chengsong
Beijing Childrens Hospital,Capital Medical University
Outcome results
None listed