Influenza Virus Infection.
Conditions
Interventions
Among patients allocated to the baloxavir group, patients with 80 kg body weight at screening will receive four baloxavir 20-mg tablets.
Patients allocated to the oseltamivir group will receive one o
Sponsors
Mukae Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients for whom voluntary written consent to participate in the study can be obtained personally 2) Patients aged 75 years or older at the time of informed consent 3) Presence of at least one each of the following general and respiratory symptoms associated with influenza, with severity of moderate or higher (with the exception of chronic symptoms or other symptoms that existed 30 days before the onset of influenza) at the time of informed consent and persisting at screening a. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) b. Respiratory symptoms (cough, sore throat, or nasal congestion) 4) Patients with fever of =>37.5 degrees Celsius (axillary) within 12 hours before pre-dose examination (screening ) 5) Influenza-positive patients with rapid influenza diagnostic test at screening **If a rapid influenza diagnostic test or any other influenza virus detection method has been already performed in routine clinical practice within 48 hours of onset as inclusion criteria 6), the results can be determined. 6) Patients in whom the time interval between the onset of symptoms and the pre-dose examination is 48 hours or less. Symptomatic onset is defined as follows: a. Time of the first increase in body temperature (an increase by at least 1 degrees Celsius from normal body temperature) b. Time when the patient newly experiences at least one general or respiratory symptom
Exclusion criteria
Exclusion criteria: 1) Patients with severe influenza requiring hospitalization for treatment1)Patients with severe influenza requiring hospitalization for treatment 2) Patients who are allergic to baloxavir /oseltamivir or have a history of clinically relevant intolerance to baloxavir /oseltamivir 3) Patients who are severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive or with suspected coronavirus disease 2019 (COVID-19) 4) Patients who are unable to swallow baloxavir tablets or oseltamivir capsules 5) Patients with any concurrent infection requiring systemic antimicrobial treatment at the time of screening 6) Patients with poorly controlled metabolic disease (including diabetes) 7) Patients on dialysis and patients with severe renal impairment (defined as eGFR of 20 mg or equivalent doses of corticosteroids 14) Patients who received baloxavir marboxile (Xofluza), peramivir (Rapiacta), Laninamivir (Inavir), oseltamivir (Tamiflu, Oseltamivir Capsules 75mg "Sawai"), zanamivir (Relenza), or amantadine (Symmetrel) within 14 days before screening 15) Patients who will require prohibited concomitant medication during the study period in the opinion of the investigator/subinvestigator 16) Patients who are participating other clinical studies 17) Patients who had participated in this clinical study 18) Patients that the investigator/subinvestigator deems difficult to be participated to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of influenza disease: Time to improvement of influenza symptoms (adjusted for existing symptoms) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time to alleviation of the seven influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) 2) Time to improvement of the four general symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) 3) Time to improvement of the three respiratory symptoms (cough, nasal congestion, and sore throat) 4) Time to resolution of fever to normal temperature 5) Proportion of patients with resolution of fever to normal temperature at each time point of evaluation 6) Body temperature at each time point of evaluation 7) Influenza virus serum antibody titers at each time point of evaluation 8) Time to resolution of gastrointestinal symptoms (diarrhea and impaired appetite) 9) Time to improvement of each symptom of influenza 10) Proportion of patients who underwent additional treatments or procedures for underlying respiratory disease 11) Changes in respiratory function parameters (CAT total score, oxygen saturation [SpO2]) from baseline to each time point of evaluation, up to 2 weeks after the start of treatment 12) Time to return to pre-influenza health 13) Requirement for systemic antimicrobial use for influenza secondary infections 14) Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, X-ray-documented pneumonia) 15) Household infection rate for influenza after the start of the study | — |
Contacts
Public ContactTakahiro Takazono
Nagasaki University Hospital
Outcome results
None listed