UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041681 |
|---|---|
| Receipt number | R000047579 |
| Scientific Title | ommunity-based prospective observational cohort study of respiratory syncytial virus (RSV) infection among the infants under 1yr of age in Japan. |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/05/17 14:28:25 |
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Basic information
Public title
Community-based prospective observational cohort study of respiratory syncytial virus (RSV) infection among the infants under 1yr of age in Japan.
Acronym
Cohort study of RSV infection among the infants under 1yr of age in Japan.
Scientific Title
ommunity-based prospective observational cohort study of respiratory syncytial virus (RSV) infection among the infants under 1yr of age in Japan.
Scientific Title:Acronym
Cohort study of RSV infection among the infants under 1yr of age in Japan.
Region
| Japan |
Condition
Condition
Respiratory syncytial virus infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the incidence of RSV LRTI in infants according to month of age.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate the incidence of RSV LRTI in infants according to month of age.
Key secondary outcomes
To describe clinical epidemiology and economic burden of LRTI and RSV LRTI including severity, complications, hospitalization rate, disease course, patient pathway, factors contributing to severity and medical resource consumption according to month of age and week.
To describe molecular epidemiology of RSV LRTI and LRTI attributable to other pathogens to understand whole picture of causative pathogens of infant LRTI using FilmArray panel and NGS.
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
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children under 1 year of age, presenting to participating facilities with LRTI symptoms, and residents in the catchment area of Chiba prefecture in Japan.
Key exclusion criteria
If the guardians of the patient deny to take part in this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naruhiko |
| Middle name | |
| Last name | Ishiwada |
Organization
Medical mycology research center, Chiba University
Division name
Department of Infectious Diseases
Zip code
260-8673
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432262799
ishiwada@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Naruhiko |
| Middle name | |
| Last name | Ishiwada |
Organization
Medical Mycology Research Center, Chiba University
Division name
Department of Infectious Diseases
Zip code
260-8673
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
0432262799
Homepage URL
ishiwada@faculty.chiba-u.jp
Sponsor or person
Institute
Medical Mycology Research Center, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Sanofi pasteur
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
Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
+81432262799
inohana-shien@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
RSV00034
Org. issuing International ID_1
Sanofi pasteur
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）、千葉市立海浜病院（千葉県）、千葉県こども病院（千葉県）、千葉メディカルセンター（千葉県）、五井病院（千葉県）、帝京大学ちば総合医療センター（千葉県）、千葉ろうさい病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | 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
Observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047579
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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