UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030477 |
|---|---|
| Receipt number | R000034800 |
| Scientific Title | Identification of causative pathogen using real-time PCR in pediatric patients with encephalitis/encephalopathy |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2020/09/26 14:12:18 |
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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
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
yuuta_aizawa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034800
| 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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