UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of factors of virus and host sassociated with severe Enterovirus diseases
Title of the study (Brief title)	Study of severe Enterovirus diseases
Region	Japan

Condition
Condition	Enterovirus71 infection
Classification by specialty	Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to identify that factors of virus and host associated with severe Enterovirus71 diseases.
Basic objectives2	Others
Basic objectives -Others	virology
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Analysis of virus factor associated with severe Enterovirus71 diseases
Key secondary outcomes	Etiology of Enterovirus71 infection

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	0 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients detected Enterovirus in blood or cerebrospinal fluid
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	Yuho Horikoshi
Organization	Tokyo Metropolitan Children's Medical Center
Division name	infectious diseases
Address	2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL	0423005111
Email	yuho71@hotmail.com

Public contact
Name of contact person	Mihoko Isogai
Organization	Tokyo Metropolitan Children's Medical Center
Division name	infectious diseases
Address	2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL	0423005111
Homepage URL	http://www.byouin.metro.tokyo.jp/shouni/tiken/rinshou_shounin.html
Email	mihoko.isogai@gmail.com

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Metropolitan Institute of Medical Science
Name of secondary funｄer(s)

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	東京都立小児総合医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 06 Month 30 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2026 Year 06 Month 30 Day
Date of closure to data entry	2026 Year 07 Month 31 Day
Date trial data considered complete	2027 Year 07 Month 31 Day
Date analysis concluded	2028 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Years, Sex, Body weight, underling diseases, labodata, vital signs, result of PCR

Management information
Registered date	2016 Year 08 Month 24 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027342