UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043000 |
|---|---|
| Receipt number | R000048526 |
| Scientific Title | A study on dynamics of anti-influenza drug low susceptibility virus in household transmission |
| Date of disclosure of the study information | 2021/01/14 |
| Last modified on | 2022/07/18 16:56:39 |
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Basic information
Public title
A prospective,observational study on influenza virus infection part2:A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Acronym
A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Scientific Title
A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Scientific Title:Acronym
A study on dynamics of anti-influenza drug low susceptibility virus in household transmission
Region
| Japan |
Condition
Condition
Type A influenza virus infection
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Pediatrics | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate viral dynamics of amino acid substituted virus on target protein after treatment of baloxavir marboxil or oseltamivir phosphate
Basic objectives2
Others
Basic objectives -Others
major secondary objectives:
To investigate viral dynamics of variants after transmission
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
RNA ratio of variants (PA/I38X, NA/H275Y) compared to wild type in index and secondary patients when transmission occue in addition to whole virus titer
Key secondary outcomes
RNA ratio of variants (PA/I38X, NA/H275Y) compared to wild type in index and secondary patients when transmission occue in addition to whole virus titer
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
For index and 2ndary infected patients,
patients infected influenza A judged by RIDT
patients obtain a written informed consent
For index patients
index patients who incured 2ndary infection in their household members
For 2ndary infected patients
2ndary infected patietns judged by influenza type/atype during 24hr - 7days after onset of infection of index patient
housemmate with index patient
Key exclusion criteria
Patients had been treated with anti-influenza drug within 2weeks prior to 1st visit for current infection
Patients with SARS-CoV(+) or had been diagnosed COVID-19 for current infection
Target sample size
860
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Hirotsu |
Organization
Hirotsu medical clinic
Division name
internal medicine, pediatrics
Zip code
2130011
Address
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki
TEL
+81-44-822-1933
non@hirotsu.ptu.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Saisho |
Organization
Shionogi&Co.,Ltd.
Division name
Medical affairs
Zip code
541-0045
Address
1-8 Doshomachi, 3-Chome, Chuo-ku, Osaka
TEL
+81-80-6140-9391
Homepage URL
yutaka.saisho@shionogi.co.jp
Sponsor or person
Institute
Hirotsu medical clinic
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
still under
Address
still under
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
| 2021 | Year | 01 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Variants (PA/I38X, NA/H275YH)dynamics (RNA ratio of Wild/variant, virus titer) after infection
Management information
Registered date
| 2021 | Year | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
