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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023049
Receipt No. 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

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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
Email 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
Email sonare.since1192@gmail.com

Sponsor
Institute National Centre for Global Health and Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026569

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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