UMIN-CTR Clinical Trial

Public title

Comparison of Effectiveness in Reducing Severity of Illness in Influenza Pediatric Outpatients Treated With BXM or Neuraminidase Inhibitors
- 2018/19, 2019/20 influenza season data -

Acronym

Comparison of Effectiveness in Reducing Severity of Illness in Influenza Pediatric Outpatients Treated With BXM or Neuraminidase Inhibitors
- 2018/19, 2019/20 influenza season data -

Scientific Title

Comparison of Effectiveness in Reducing Severity of Illness in Influenza Pediatric Outpatients Treated With BXM or Neuraminidase Inhibitors
- 2018/19, 2019/20 influenza season data -

Scientific Title:Acronym

Comparison of Effectiveness in Reducing Severity of Illness in Influenza Pediatric Outpatients Treated With BXM or Neuraminidase Inhibitors
- 2018/19, 2019/20 influenza season data -

Region

Japan

Condition

Influenza virus infection

Classification by specialty

Infectious disease

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the efficacy of baloxavir marboxil in reducing the severity of illness in pediatric influenza patients during the 2018/2019 and 2019/2020 influenza seasons using the insurance claims database as a control for each neuraminidase inhibitor drug.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Hospitalization incidence (days 2-14) with the date of diagnosis of influenza infection as Day 1

Key secondary outcomes

Incidence of each of the following events from Day 2 to Day 14
- Antibacterial oral administration
- Antibacterial injectable administration
- Pneumonia
- Additional anti-influenza drug use
- Infusion
- Febrile seizures
- Each secondary end points with hospitalization

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

5

years-old

<=

Age-upper limit

12

years-old

>

Gender

Male and Female

Key inclusion criteria

1, Patients whose the date of earliest diagnosis of influenza virus infection is within each influenza season (day 1) during the enrollment period of each influenza season (October 1, 2018 to April 17, 2019, or October 1, 2019 to April 17, 2020) and patients has an observable period from 6 months before Day 1 (that is, the observation start date in the parameter table is more than 6 months before the month of Day 1). Influenza virus infection is defined by the ICD-10 small classification code without a suspicion flag.
2, Patients with BXM, OTV, ZNV, or LNV administration date as anti-influenza virus drugs on Day 1.

Key exclusion criteria

1, Patients with an admission receipt or DPC receipt with the date of admission from 90 days before Day 1
2, Patients who have administration dates of an antibacterial drugs from 90 days prior to Day 1
3, Patients who has a diagnosis (no suspicion flag) of pneumonia in receipts for the past 3 months from the month with Day 1 to excluding the month with Day 1, or has a medical starting date before Day 1 to including Day 1 in receipts for the month including Day 1.
4, Patients who have infusions on Day 1
5, Patients with febrile seizures on Day 1 with medical starting date (no suspicion flag)
6, Patients who died on Day 1 (Patients for whom "terminate in death" is described in the disease name in the receipt for the month including Day 1 and whose last date of medical treatment in the receipt is the same as Day 1).
7, Patients under 5 years old or 12 years old or older as of Day 1
8, Patients with multiple influenza anti-influenza drugs (BXM, OTV, ZNV, LNV, or PRV) dispensing dates on Day 1.

Target sample size

200000

Name of lead principal investigator

1st name	Isao
Middle name
Last name	Miyairi

Organization

Hamamatsu University School of Medicine

Division name

Department of Pediatrics

Zip code

431-3192

Address

20-1, Handayama 1-chome, Higashi-ku, Hamamatsu city, Shizuoka

TEL

053-435-2310

Email

miyairi@hama-med.ac.jp

Name of contact person

1st name	Shogo
Middle name
Last name	Miyazawa

Organization

Shionogi & Co., Ltd.

Division name

Data Science Department

Zip code

541-0047

Address

4F, Midosuji MTR Building, 6-3, Awajimachi 3-chome, Chuo-ku, Osaka-shi, Osaka

TEL

+819030566073

Homepage URL

Email

shogo.miyazawa@shionogi.co.jp

Institute

Shionogi & Co., Ltd.

Institute

Department

Personal name

Organization

Shionogi & Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NA

Address

NA

Tel

9999999

Email

XXXX@XXXX

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

24

Day

URL releasing protocol

https://doi.org/10.1016/j.jiac.2025.102606

Publication of results

Published

URL related to results and publications

https://doi.org/10.1016/j.jiac.2025.102606

Number of participants that the trial has enrolled

196749

Results

Of 196,749 included patients (2018/19:n=103,709, 2019/20:n=93,040), 20.9% received baloxavir, 38.8% oseltamivir, 28.7% laninamivir, and 11.6% zanamivir. The incidence of hospitalization from Day 2-14 was significantly lower for baloxavir than for others. The adjusted risk ratio (95% confidence interval) for oseltamivir, laninamivir, and zanamivir were 1.86 (1.30-2.68), 2.11 (1.37-3.25), and 1.90 (1.31-2.77), respectively, compared with baloxavir.

Results date posted

2025

Year

08

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2025

Year

01

Month

07

Day

Baseline Characteristics

Oseltamivir group had a higher proportion of patients aged 5-10 years than other treatment groups. Most patients had influenza A (61-70%).

Participant flow

The total number of recorded individuals in the JMDC database was 8,725,331 in the 2018/19 season and 9,502,493 in the 2019/20 season. The study population included 196,749 patients (Season 2018/19:103,709, Season 2019/20: 93,040). Of the 1,326,247 patients who had Day 1 included during the enrollment period and who were continuously registered in the database 6 months and more prior to Day 1, 871,545 (65.7%) were aged 12 years and higher, 82,074 (6.2%) were aged 10-12 years, 240,525 (18.1%) were aged 5-10 years, and 132,103 (10.0%) were aged <5 years.

Adverse events

Not evaluated.

Outcome measures

The incidence of hospitalization from Day 2-14 was significantly lower for the baloxavir group than for the oseltemivir, laninamivir, and zanamivir groups. The adjusted risk ratio (95% confidence interval) for oseltamiver, laninamivir, and zanamivir were 1.86 (1.30-2.68), 2.11 (1.37-3.25), and 1.90 (1.31-2.77), respectively, compared to baloxavir.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

07

Month

18

Day

Date of IRB

2045

Year

12

Month

31

Day

Anticipated trial start date

2023

Year

07

Month

18

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

No ethics committee required as the study uses an anonymized database

Registered date

2023

Year

07

Month

21

Day

Last modified on

2025

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058973