UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051678 |
|---|---|
| Receipt number | R000058973 |
| 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 - |
| Date of disclosure of the study information | 2023/07/24 |
| Last modified on | 2023/07/21 12:30:00 |
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Basic information
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
Condition
Influenza virus infection
Classification by specialty
| Infectious disease | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
miyairi@hama-med.ac.jp
Public contact
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
shogo.miyazawa@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
9999999
XXXX@XXXX
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 18 | Day |
Date of IRB
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
Other related information
None
Management information
Registered date
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058973
