UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053258 |
|---|---|
| Receipt number | R000060770 |
| Scientific Title | A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2026/01/05 17:26:09 |
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Basic information
Public title
A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients
Acronym
A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients
Scientific Title
A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients
Scientific Title:Acronym
A prospective observational study to evaluate the relationship between adherence to anti-influenza medication and effectiveness in pediatric influenza patients
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between adherence to anti-influenza medication and the duration of influenza illness in children aged 6-11 years, who were prescribed anti-influenza medication at a pharmacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of influenza illness from the first administration of medication to resolution
Influenza illness: fever (37.5 or higher than 37.5 degree Celsius), cough or nasal congestion/runny nose
Key secondary outcomes
- Number of days from the first administration of medication to the return of normal body temperature (below 37.5 degree Celsius)
- Number of days from the first administration of medication to the resolution of each of the 7 influenza symptoms ("cough", "sore throat", "headache", "nasal congestion/runny nose", "feeling feverish/chills", "muscle or joint pain", "fatigue")
- Number of days from the first administration of medication to the resolution of all influenza symptoms
- Presence or absence of influenza symptoms ("cough", "nasal congestion/runny nose", "body temperature") on day 5 of medication
- Presence or absence of antipyretic effect (return to normal body temperature below 37.5 degree Celsius) on day 5 of medication
- Presence or absence of any of the 7 influenza symptoms ("cough", "sore throat", "headache", "nasal congestion/runny nose", "feeling feverish/chills", "muscle or joint pain", "fatigue") on day 5 of medication
- Presence or absence of each influenza symptom on day 5 of medication
- Presence or absence of influenza-related complications (pneumonia, bronchitis, sinusitis, otitis media, influenza encephalopathy or encephalitis, febrile seizures, myositis)
- Hospitalization status
- Compliance rate of medication adherence and breakdown of reasons for difficulties in adherence
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who can provide consent for clinical research participation from their parent or legal guardian. In addition, informed assent should be obtained from the patient as much as possible.
2. Pediatric influenza patients aged 6 -11 years.
3. Patients diagnosed with influenza virus infection and prescribed anti-influenza medication.
4. Patients who can be expected to take medication within 2 days of the onset of influenza.
Key exclusion criteria
1. Patients who refuse to participate in the study
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Naganuma |
Organization
Qol Co., Ltd.
Division name
Qol Academy / Division of Education and Training
Zip code
105-8452
Address
37F, Shiroyama Trust Tower, 4-3-1 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-6430-9058
m-naganuma@qol-net.co.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kobayashi |
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
080-8502-5720
Homepage URL
masayuki.kobayashi@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
Qol Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
0000000000
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
| 2024 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.11150/kansenshogakuzasshi.e24019
Number of participants that the trial has enrolled
2556
Results
This observational study was conducted to investigate the relationship between adherence to the anti-influenza medication regimen and the number of days from the start of drug administration to resolution of influenza symptoms in pediatric patients aged 6 to 12 years with influenza. The time to resolution of influenza symptoms was significantly shorter in the adherent group (1305 patients) than in the non-adherent group (312 patients) (p<0.0001).
Results date posted
| 2026 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Of the primary analysis population, 80.7% (1,355 cases) were adherent and 19.3% (324 cases) were non-adherent. The breakdown of anti-influenza medications taken in the primary analysis population was baloxavir (20.5%; 345 cases), oseltamivir (31.6%; 531 cases), laninamivir (40.6%; 682 cases), and zanamivir (7.2%; 121 cases). The proportion of patients who adhered to medication in each medication group (hereinafter referred to as "adherence rate") was 98.6% (340/345 cases) for baloxavir, 77.0% (409/531 cases) for oseltamivir, 76.8% (524/682 cases) for laninamivir, and 67.8% (82/121 cases) for zanamivir. The proportion of patients aged 6-8 year was 49.4% (669/1,355 cases) in the medication adherence group and 59.0% (191/324 cases) in the medication non-adherence group.
Participant flow
A total of 2,556 study participants consented during the study period, and no patients withdrew consent. Of the eligible patients, 745 who did not respond to both questionnaires were excluded. Furthermore, 119 patients with irregular response dates, 99 with incomplete data on the date of influenza virus infection onset, medication initiation date, and dispensing date, 2 patients whose prescribed anti-influenza medication was not baloxavir, oseltamivir, zanamivir, or laninamivir, 11 patients with incomplete responses to the questionnaire to medication compliance/non-compliance, and 13 patients whose medication initiation date was not between 0 and 7 days were excluded. The primary analysis population consisted of 1,679 patients.
Adverse events
Not investigated
Outcome measures
The results of the analysis of the primary endpoint in the primary analysis population showed that the median number of days until influenza symptoms resolution in each group was 5.0 days in the adherent group and 6.0 days in the non-adherent group, with the difference between the two groups [95% confidence interval] (days) being -1.0 [-1.0, 0.0], meaning that the number of days until influenza symptoms resolution in the adherent group was significantly shorter than in the non-adherent group (p<0.0001). The proportion of discontinued cases was 25.5% in the adherent group and 37.5% in the non-adherent group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2024 | Year | 01 | Month | 02 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060770
