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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041681
Receipt No. 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 2021/03/05

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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
Email 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
Email ishiwada@faculty.chiba-u.jp

Sponsor
Institute Medical Mycology Research Center, Chiba University
Institute
Department

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
Email 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
2022 Year 12 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
2021 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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