UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023049 |
|---|---|
| Receipt number | R000026569 |
| Scientific Title | Epidemiology study about febrile illness in Japanese travelers using multiplex PCR |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2020/07/10 09:07:51 |
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Basic information
Public title
Epidemiology study about febrile illness in Japanese travelers using multiplex PCR
Acronym
Epidemiology study about febrile illness in Japanese travelers
Scientific Title
Epidemiology study about febrile illness in Japanese travelers using multiplex PCR
Scientific Title:Acronym
Epidemiology study about febrile illness in Japanese travelers
Region
| Japan |
Condition
Condition
febrile illness in travelers
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the pathogens of the febrile illness in travelers using multiplex PCR-based detection.
Basic objectives2
Others
Basic objectives -Others
epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to evaluate the pathogens of the febrile illness in travelers using multiplex PCR-based detection.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who presented to NCGM between 1 January 2016 and 31 March 2018, and have fever more than 38 degree after travel
Key exclusion criteria
the patient diagnosed as malaria
the patient diagnosed as dengue fever
Patients who have fever before trip.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
Toyama
TEL
+81332027181
sonare.since1192@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kutsuna |
Organization
National Centre for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
Toyama
TEL
+81332027181
Homepage URL
sonare.since1192@gmail.com
Sponsor or person
Institute
National Centre for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Centre for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1
Tel
+81332027181
skutsuna@hosp.ncgm.go.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 | 07 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4994370/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4994370/
Number of participants that the trial has enrolled
20
Results
Twenty cases were enrolled and one was positive for chikungunya fever
Results date posted
| 2020 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with fever after returning from overseas
Participant flow
Patients with fever after returning home from overseas who have seen the NCGM participate with verbal consent
Adverse events
None
Outcome measures
One out of 20 cases revealed a diagnosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
