UMIN-ICDS 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 | 2024/01/02 15:27:38 |
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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
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 | 12 | Month | 22 | Day |
Date of IRB
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
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2024 | Year | 01 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060770
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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