UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020464 |
|---|---|
| Receipt number | R000023646 |
| Scientific Title | National survey about the aggravation by respiratory syncytial virus infection in children with immunodeficiency |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2023/01/11 09:56:42 |
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Basic information
Public title
National survey about the aggravation by respiratory syncytial virus infection in children with immunodeficiency
Acronym
National survey about trespiratory syncytial virus infection in children with immunodeficiency
Scientific Title
National survey about the aggravation by respiratory syncytial virus infection in children with immunodeficiency
Scientific Title:Acronym
National survey about trespiratory syncytial virus infection in children with immunodeficiency
Region
| Japan |
Condition
Condition
respiratory syncytial virus (RSV)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate a rate of hospitalization and an aggravation rate by RS virus infection in the immunodeficiency child younger than five years, and we compare the situation of RS virus infection aggravation before and after the adaptation addition of parivizumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the rate of hospitalization by RSV
Key secondary outcomes
Change of the rate of hospitalization by the RSV infection aggravation, and
Rate of hospitalization at the age that is higher than a child targeted for adaptation
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
| 1 | months-old | <= |
Age-upper limit
| 60 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
There is a medical treatment record during the period of from April, 2010 to March, 2015 and does an affected child entering three following categories among 0-5 years old within children at some point during the period with criteria for selection.
-Under the immunosuppressive therapy enforcement during the high-dose steroid therapy enforcement (rheumatic diseases, collagen diseases, renal diseases)
-Down's syndrome (except the congenital heart failure (CHD))
-After organ transplantation
Key exclusion criteria
Except the above
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Mori |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Clinical Immunology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
+81-3-5803-4677
mori.phv@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Mori |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Clinical Immunology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5803-4876
Homepage URL
mori.phv@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Abbie
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
Tokyo Medical and Dental University
Address
1-4-45 Yushima, Bunkyo-ku
Tel
+81-3-5803-5612
tiken.crc@tmd.ac.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
| 2016 | Year | 02 | Month | 01 | 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
5000
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Non-publication
Management information
Registered date
| 2016 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023646
