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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028380
Receipt No. R000032489
Scientific Title Effectiveness of de-escalation for bacteremia: Open-label randomized non-inferior trial.
Date of disclosure of the study information 2017/08/30
Last modified on 2017/07/26

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Basic information
Public title Effectiveness of de-escalation for bacteremia: Open-label randomized non-inferior trial.
Acronym Effectiveness of de-escalation for bacteremia
Scientific Title Effectiveness of de-escalation for bacteremia: Open-label randomized non-inferior trial.
Scientific Title:Acronym Effectiveness of de-escalation for bacteremia
Region
Japan

Condition
Condition bacteremia
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to investigate the non-inferiority of de-escalation for adults with bacteremia, which was judged to be eligible for de-escalation, by means of randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30-day mortality
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 de-escalation
Interventions/Control_2 no de-escalation
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients with bacteremia with positive blood cultures, diagnosed by Infectious Diseases (ID) doctors, treated with broad spectrum antibiotics, and judged to be eligible for de-escalation by ID doctor.
Key exclusion criteria Disagreed to participate in the trial either by the patient or treating physicians.
Target sample size 164

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 Kusunokicho 7-5-2, Chuoku, Kobe
TEL 078-382-6297
Email kentaroiwata1969@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toko Nakata
Organization Kobe University
Division name Division of Infectious Diseases
Zip code
Address Kusunokicho 7-5-2, Chuoku, Kobe
TEL 078-382-6297
Homepage URL
Email kobeid@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization self
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
2017 Year 08 Month 30 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 07 Month 26 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032489

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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