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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017224
Receipt No. R000019941
Scientific Title An evaluation of the efficacy and safety of anti-infective agent.
Date of disclosure of the study information 2015/04/21
Last modified on 2017/10/25

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Basic information
Public title An evaluation of the efficacy and safety of anti-infective agent.
Acronym An evaluation of the efficacy and safety of anti-infective agent.
Scientific Title An evaluation of the efficacy and safety of anti-infective agent.
Scientific Title:Acronym An evaluation of the efficacy and safety of anti-infective agent.
Region
Japan

Condition
Condition infection
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An evaluation of the efficacy and safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes An evaluation of the efficacy and safety
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of anti-infective agent
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

Not applicable
Gender Male and Female
Key inclusion criteria In patients and out patients treated with anti-infective agent
Key exclusion criteria Nothing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hasegawa
Organization Keio University School of Medicine
Division name Center of Infectious Diseases and Infection Control
Zip code
Address 35 Shinanomachi Shinjyukuku Tokyo
TEL 03-3353-1211
Email n-hasegawa@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Iketani
Organization Keio University Hospital
Division name Center of Infectious Diseases and Infection Control
Zip code
Address Center of Infectious Diseases and Infection Control
TEL 03-3353-1211
Homepage URL http://www.hosp.keio.ac.jp/annai/shinryo/infectioncontrol/
Email osamu.iketani@adst.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio 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
2015 Year 04 Month 21 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
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2017 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019941

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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