UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005150 |
|---|---|
| Receipt number | R000006099 |
| Scientific Title | Research on the identification of the causative agent of the Kawasaki disease |
| Date of disclosure of the study information | 2011/03/03 |
| Last modified on | 2011/02/28 10:23:09 |
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Basic information
Public title
Research on the identification of
the causative agent of the Kawasaki disease
Acronym
Research on the identification of
the causative agent of the Kawasaki disease
Scientific Title
Research on the identification of
the causative agent of the Kawasaki disease
Scientific Title:Acronym
Research on the identification of
the causative agent of the Kawasaki disease
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Kawasaki disease has been thought to be an infectious disease, however , the causative agent has not yet been identified for long time. The aim of this research is the identification of the causative agent of Kawasaki disease. The identification of the agent will promote research on the pathogenesis of the disease, and the development of vaccine and better treatment rather than gamma-globulin therapy for this disease.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of the causative agent of the Kawasaki disease
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
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)cases who meet the diagnostic criteria of the Kawasaki disease
2)Informed consent by the document should be obtained from parents of the patient.
Key exclusion criteria
1)Cases that physicians recognize the patients not to be eligible for empty of this research.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahashi Kazuo |
Organization
Osaka Prefectural Institute of Public Health
Division name
Department of Infectious Diseases
Zip code
Address
3-69, Nakamichi 1-chome, Higashinari-ku, Osaka 537-0025 Japan
TEL
+81-06-6972-1321
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahashi Kazuo |
Organization
Osaka Prefectural Institute of Public Health
Division name
Department of Infectious Diseases
Zip code
Address
TEL
+81-06-6972-1321
Homepage URL
takahashi@iph.pref.osaka.jp
Sponsor or person
Institute
Osaka Prefectural Institute of Public Health
Institute
Department
Personal name
Funding Source
Organization
OSAKA FOUNDATION FOR THE PREVENTION OF CANCER AND CARDIOVASCULAR DISEASES
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2011 | Year | 03 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Throat swab, nasal aspirates and 1ml of residual peripheral blood of the patients aged under 3 years are collected. The specimens are numbered and anonymous with connection to their clinical record. The specimens are transported to the Osaka Prefectural Institute of Public Health for virus testing and the preservation of the specimens. The specimens are screened by PCR for the presence of genes of micro organisms which infect a respiratory tract of humans. The specimens are collected three times, on admission, one week later from the onset and one month later.
Management information
Registered date
| 2011 | Year | 02 | Month | 28 | Day |
Last modified on
| 2011 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006099
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
