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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002675
Receipt No. R000002975
Scientific Title Study on effectiveness of treatment against influenza like illness(ILI) and swine origin influenza A (H1N1) virus infection
Date of disclosure of the study information 2009/10/29
Last modified on 2015/10/27

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Basic information
Public title Study on effectiveness of treatment against influenza like illness(ILI) and swine origin influenza A (H1N1) virus infection
Acronym Study on the treatment of Novel influenza
Scientific Title Study on effectiveness of treatment against influenza like illness(ILI) and swine origin influenza A (H1N1) virus infection
Scientific Title:Acronym Study on the treatment of Novel influenza
Region
Japan

Condition
Condition Influenza like illness (ILI) and Swine origin influenza A(H1N1) virus infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The ideal treatment strategy of swine origin influenza A(H1N1) virus infection is unknown.
This study evaluate the effectiveness of this virus infection and ILI, making hospitalization and mortality on day 7 as primary outcome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hospitalization and mortality on day 7
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oseltamivir
Interventions/Control_2 zanamivir
Interventions/Control_3 Mao-to
Interventions/Control_4 acetaminophen
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria no underlying health condition
Key exclusion criteria needs hospitalization
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Iwata
Organization Kobe University
Division name Division of Infectious Diseases
Zip code
Address Kusunoki-cho 7-5-1, Chuo-ku, Kobe
TEL 0783826296
Email kiwata@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Iwata
Organization Kobe University
Division name Division of Infectious Diseases
Zip code
Address Kusunokicho 7-5-2, Chuoku, Kobe
TEL 0783826296
Homepage URL
Email kentaroiwata1969@gmail.com

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Organization
Division
Category of Funding Organization Other
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
2009 Year 10 Month 29 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 27 Day
Last modified on
2015 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002975

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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