jRCTs011200011CompletedNot Applicable
Randomized, Open-label, Active Controlled Trial of Baloxavir Malboxil in Pediatric Patients with Influenza Infection Aged 6 to 11 Years
Not provided0 sites200 target enrollmentStarted: January 12, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 6age old over to 12age old not (—)
- Sex
- All
Inclusion Criteria
- •Patients meeting all of the following criteria are selected.
- •A patient who have provided written consent to participate in clinical research from a proxy consenter.
- •Male or female patients aged 6 to 11 years at the time of acquisition of the Ascent according to consent and age.
- •Patients who met all of the following criteria and were diagnosed with influenza virus infection.
- •Fever is more than 38 degrees (axillary temperature) at screening
- •In patients aged 6 to 11 years; at least one of respiratory symptoms (cough, nasal discharge/nasal congestion) associated with influenza virus infection are present with a severity of moderate or greater.
- •Positive rapid influenza diagnostic test (RIDT) with nasal swab, nasal aspirate, throat swab, or nasal drip (Other appropriate samples) or positive by an influenza test method covered by insurance, such as telescope for endoscopy.
- •Patients within 48 hours of onset (At the time of screening). However, onset is defined as the first confirmed fever of 37.5 degree centigrade or higher.
- •Patients judged by the investigator or subinvestigator (Investigators, etc.) to be able to take (swallowing) Baloxavir tablets and Oseltamivir capsules,tablets or dry syrup.
- •A parent/guardian who is willing and able to comply with the research requirements at the discretion of the investigator, etc.
- •Patients who are able to comply with the study requirements, depending on their level of understanding.
- •Patients who weigh 10 kg or more at screening.
Exclusion Criteria
- •Patients who meet any of the following criteria are excluded:.
- •Patients with severe symptoms due to influenza virus infection who are considered to require inpatient treatment.
- •Patients with chronic respiratory disease including uncontrolled bronchial asthma.
- •Patients with hepatitis/cirrhosis.
- •Patients with neurological disorders and neurodevelopmental disorders (Including brain, spinal, peripheral, and muscle disorders).
- •Patients with endocrine disorders (Diabetes, thyroid disease, adrenal gland abnormalities, etc.).
- •Patients with heart disease (Congenital heart disease, congestive heart failure, coronary artery disease, etc., excluding patients with hypertension only) during drug therapy.
- •Patients receiving systemic corticosteroids or immunosuppressive therapy.
- •Patients with primary immunodeficiency syndrome.
- •Patients with severe renal impairment (CCr: more than 30 (mL/min) or eGFR more than 30 (mL/min/1.73 m2)).
- •Patients with human immunodeficiency virus (HIV) infection.
- •Patients with malignancy within the past 5 years
- •Patients with consciousness disturbed, abnormal behavior * (Sudden start, jump, or other unexpected behavior that, if not stopped, may affect life) or convulsions at the time of screening, or those complicated by encephalitis or encephalopathy.
- •"Nationwide trend research on abnormal behavior during influenza-like illness"
- •Patients with a history of encephalitis/encephalopathy, epilepsy not controlled with antiepileptic drugs, or abnormal behavior associated with influenza virus infection * (Sudden start, jump, or other unexpected behavior that, if not stopped, may affect life) within the past 2 years.
- •"Nationwide trend research on abnormal behavior during influenza-like illness"
- •Patients with infections requiring systemic antimicrobial therapy and/or antiviral (Exclude anti-influenza drugs) therapy at screening.
- •Patients judged by the investigator etc. to require the use of prohibited concomitant drugs during the study period.
- •Patients who received valoxavir (Zofruza), peramivir (RAPIACTA), raninamivir (Inaville), oseltamivir (Tamiflu), zanamivir (Relenza), or amantadine (Simmetrel) within 30 days before screening.
- •Patients with allergies to anti-influenza virus drugs and/or acetaminophen and/or a history of clinically relevant intolerance.
- •Patients with SARS-CoV -2 positivity or suspected COVID-
- •(The SARS-CoV -2 rapid diagnostic test should be performed according to the New Coronavirus Infection COVID-19 Clinical Practice Guide (Medical Guide Review Committee) and negative for SARS-CoV -2 at entry.)
- •Patients with a severe underlying disorder that may affect evaluation.
- •Patients who have difficulty drawing blood from veins.
- •Patients person who have received the study drug or unapproved drug for 30 days or has not passed 5 times the half-life at the time of screening.
- •Patients with a disease or condition determined by the investigator, etc. to be difficult to ensure patient safety or the quality of the study data.
- •Patients judged to be inappropriate to participate in the clinical study by the investigator, etc.
- •A post-menarche female patient who wishes to become pregnant during pregnancy or during a clinical study. Or a lactating woman.
Outcomes
Primary Outcomes
-
Time to alleviation of symptom
Secondary Outcomes
- Time to continuous resolution of influenza symptoms (Cough, Nasal discharge/nasal congestion, body temperature)(last at least 72 hours)
- Time to return to normal temperature(last at least 12 hours)
- Time to continuous return to normal temperature(last at least 72 hours)
- Whether pyrexia was resolved to normal more than 37.5 degrees at each time point
- Body temperature at each time point
- Time to resolution of 7 symptoms of influenza (Cough, sore throat, headache, Nasal discharge/nasal congestion, Fever or chills, Pain in muscles or joints, tiredness)(last at least 21.5 hours)
- Time to resolution of each influenza symptom(last at least 21.5 hours)
- Presence or absence of flu-related complications (Radiographically confirmed pneumonia, bronchitis, sinusitis, and otitis media)
- Presence or absence of influenza-related complications unique to pediatric patients (Influenza encephalitis or encephalopathy, febrile convulsion, myositis)
- Death or hospitalization due to influenza-related complications and influenza-related complications unique to pediatric patients
- Use or nonuse of antibiotics
Investigators
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