Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study

Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study - Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035028

Enrollment

600

Registered

2018-11-27

Start date

2018-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Interventions

Baloxavir marboxil Oseltamivir Laninamivir

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)A positive rapid antigen test for influenza is required 2)Fever >=38 degree (axillary) in the pre-dose examination 3)Body weight more than 10kg

Exclusion criteria

Exclusion criteria: 1)Patients or their parents do not accept the assigned drug 2)A symptom duration of more than 48 hours 3)Patients who have any chronic respiratory disease, cardiovascular disease, central nervous disorder, immune dysfunction, or other chronic comorbid condition except asthma 4)Patients with severe influenza virus infection requiring inpatient treatment

Design outcomes

Primary

Measure	Time frame
The time to resolution of fever	—

Secondary

Measure	Time frame
The number of days absent from school or preschool The number of asthmatic symptoms The number of pneumonia The number of gastrointestinal symptoms The number of abnormal behaviors Drug adherence	—

Countries

Japan

Contacts

Public ContactMasaya Suematsu

Kyoto Chubu Medical Center Department of Pediatrics

masa16@koto.kpu-m.ac.jp+81-771-42-2510

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026