Influenza infection of severe or moderate state Respiratory Tract Infections
Conditions
Interventions
1. No antiviral agent (no placebo)(Not implemented in Japan due to japanese medical habit)
2. Oseltamivir twice daily for five days
3. Oseltamivir twice daily for ten days
4. Baloxavir on days 1 and 4
D053139, C000628402
Oseltamivir, baloxavir
Sponsors
Fujitani Shigeki
Saito Hiroki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Hospitalized patient and Influenza infection is confirmed by microbiological testing and Aged 6 years or older 2.Patients for whom consent to participate in this study has been obtained from the individual or a legal representative.
Exclusion criteria
Exclusion criteria: 1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment. 2.Patient is expected to be discharged from hospital within the next 24 hours 3.Previous enrollment in this Platform within the last 90 days 4.If in the Moderate State, more than 96 hours has elapsed since hospital admission 5.If in the Severe State, more than 48 hours has elapsed since commencement of sustained organ failure support 6. Patient has already received two or more doses of oseltamivir or other neuraminidase inhibitors 7. Patient has already received one or more doses of baloxavir 8. Patient is already receiving, or a clinical decision has been made to commence, an antiviral active against influenza other than oseltamivir or baloxavir, or both 9. The treating clinician believes that participation in the domain would not be in the best interests of the patient 10. Known hypersensitivity to an agent specified as an intervention in this domain will exclude a patient from receiving that agent 11. Known or suspected pregnancy will result in exclusion from interventions that include baloxavir 12. Severe renal impairment (eGFR<=10mL/min/1.73m2) or receiving renal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Landmark mortality at Day 90 post randomization 2.Among Day90 survivors, their daily respiratory support level as defined by position on a five category ordinal scale Hospitalized on extracorporeal life support (ECLS) or invasive mechanical ventilation (IMV) Hospitalized on non invasive ventilation or high flow oxygen Hospitalized on low intensity oxygen Hospitalized, no oxygen Discharged from index hospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Hospital length-of-stay 2.Mortality, censored at 90 days | — |
Countries
Australia, Canada, Europe, Japan, New Zealand, Saudi Arabia
Contacts
Public ContactNaho Shimodaira
Dee Lites Co.,Ltd
Outcome results
None listed