UMIN-CTR Clinical Trial

Basic information
Public title	Identification of causative pathogen using real-time PCR in pediatric patients with encephalitis/encephalopathy
Acronym	Identification of causative pathogen for encephalitis/encephalopathy
Scientific Title	Identification of causative pathogen using real-time PCR in pediatric patients with encephalitis/encephalopathy
Scientific Title:Acronym	Identification of causative pathogen for encephalitis/encephalopathy
Region	Japan

Condition
Condition	pediatric patients suspected of having encephalitis/encephalopathy
Classification by specialty	Medicine in general Neurology Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identify causative pathogen in pediatric patients with encephalitis/encephalopathy
Basic objectives2	Others
Basic objectives -Others	Evaluate clinical and laboratory characteristics in each pathogen
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identify causative pathogen in pediatric patients with encephalitis/encephalopathy
Key secondary outcomes

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	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who are admitted to Tokyo Metropolitan Children's Medical Center and Tokyo Metropolitan Bokutou Hospital during the study period 2. Patients at age of 18 or younger 3. Patients suspected of having encephalitis/encephalopathy the definition to suspect encephalitis/encephalopathy a)consciousness disturbance lasting for more than 24 hours, mental alteration, or personality change b)convulsion or neurologic focal sign c)cerebrospinal fluid pleocytosis d)abnormal cranial imaging (CT and/or MRI) or abnormal EEG findings 4. Patients or their guardians who have consent to participate in the study
Key exclusion criteria	1. Patients who have difficulty to obtain specimens 2. Patients who don't get informed consent 3. Patients whom a researcher consider inappropriate as a subject
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuta Aizawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of Infectious Diseases
Zip code
Address	2-8-29 Musashi-dai Fuchu-city, Tokyo, Japan
TEL	+81423005111
Email	yuuta_aizawa@tmhp.jp

Public contact
Name of contact person	1st name Middle name Last name Yuta Aizawa
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Division of Infectious Diseases
Zip code
Address	2-8-29 Musashi-dai Fuchu-city, Tokyo, Japan
TEL	+81423005111
Homepage URL
Email	yuuta_aizawa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Tokyo
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 12 Month 20 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	Completed
Date of protocol fixation	2017 Year 07 Month 28 Day
Date of IRB	2017 Year 07 Month 28 Day
Anticipated trial start date	2017 Year 07 Month 28 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective cohort study data collection from electronic medical record

Management information
Registered date	2017 Year 12 Month 20 Day
Last modified on	2020 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034800