UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039089 |
|---|---|
| Receipt number | R000040944 |
| Scientific Title | The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B infection: A prospective, observational study |
| Date of disclosure of the study information | 2020/01/09 |
| Last modified on | 2022/01/14 09:48:08 |
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Basic information
Public title
The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection: A prospective, observational study
Acronym
The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection
Scientific Title
The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection: A prospective, observational study
Scientific Title:Acronym
The effect of anti-influenza drugs on household transmission in Japanese patients with influenza A and B
infection
Region
| Japan |
Condition
Condition
Patients of any age who are diagnosed with influenza A (subtypes A/H1pdm or A/H3) or B using rapid influenza diagnostic tests (RIDTs) were eligible for inclusion
Classification by specialty
| Medicine in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using medical information in Hirotsu clinic, to evaluate the rate of influenza transmission within households new drug:Cap-dependent endonuclease inhibitor and neuraminidase inhibitors are treated, and compare them between drugs. The effects of prognostic factors(generation, age, family structure, time to start treatment from the onset) on them are also evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Daily secondary infection rate
Key secondary outcomes
Rate of household members with
secondary infections
Proportion of households with
secondary infections
Time to return to normal body temperature (no relapse at least 12hrs continuously)
Time to return to normal body temperature (no relapse at least 72hrs continuously)
Relapse of fever
Time to alleviation of symptoms (6symptoms)
Exploratory analysis of new symptomatic index
Safety
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of any age who were diagnosed with influenza A (subtypes A/H1pdm or A/H3) or B using RIDTs
Key exclusion criteria
Not applicable
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Hirotsu |
Organization
Hirotsu Clinic, Director
Division name
Internal Medicine, Pediatrics
Zip code
2130011
Address
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa, 231-0011, Japan
TEL
044-822-1933
non@hirotsu.ptu.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Hirotsu |
Organization
Hirotsu Clinic
Division name
Internal Medicine, Pediatrics
Zip code
2130011
Address
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa, 231-0011, Japan
TEL
044-822-1933
Homepage URL
non@hirotsu.ptu.jp
Sponsor or person
Institute
Shionogi & Co.,ltd
Medical affairs department
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
Meiwa hospital
Address
1-18 Kandasuda Chiyoda-Ku, Tokyo
Tel
+81-3-5543-0196
shuji.nakamura@smo-msr.co.jp
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
| 2020 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
329
Results
The data has been shown in a presentation at conference descrivbe left (on-demand movie service)
Results date posted
| 2021 | Year | 07 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
low influenza incidence
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No information about other clinical sites because of single-center study
Management information
Registered date
| 2020 | Year | 01 | Month | 08 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
