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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038633
Receipt No. R000043394
Scientific Title An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU
Date of disclosure of the study information 2019/11/30
Last modified on 2019/10/23

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Basic information
Public title An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU
Acronym An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU
Scientific Title An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU
Scientific Title:Acronym An Observational Study on the Effect of Antimicrobial Stewardship Program in ICU
Region
Japan

Condition
Condition Infectious disease
Classification by specialty
Infectious disease Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will analyze 1) the use of antimicrobial drugs, 2) the pattern of antimicrobial resistant bacteria and 3) the prognosis of patients who received antimicrobial drugs prior to and after the inception of Antibiotic Stewardship Program.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Patient outcomes 30 days after discharge from ICU
Key secondary outcomes Patient outcome at the time of discharge from ICU, Antimicrobial Use Density (AUD), Days Of Therapy (DOT), the pattern of antimicrobial resistant bacteria and antimicrobial de-escalation rate.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients admitted to the ICU
Key exclusion criteria Patients who refuse to participate in the study
Target sample size 6000

Research contact person
Name of lead principal investigator
1st name Hidenobu
Middle name
Last name Shigemitsu
Organization Tokyo Medical and Dental University, Medical hospital
Division name Department of Intensive Care Medicine
Zip code 113-8519
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-5652
Email hshiccm@tmd.ac.jp

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Mishima
Organization Tokyo Medical and Dental University, Medical hospital
Division name Department of Intensive Care Medicine
Zip code 113-8519
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-5652
Homepage URL
Email ykmishima.icu@tmd.ac.jp

Sponsor
Institute Department of Intensive Care Medicine, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, Tokyo Medical and Dental University
Address 1-5-45 Yushima Bunkyo-ku Tokyo
Tel 03-3813-6111
Email syomu1.adm@tmd.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 M2019-055
Org. issuing International ID_1 Research Ethics Committee, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 11 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
2019 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Before-After Study.
Participants: All ICU patients on the survey period.
Survey Period:
(1) Before launching Antimicrobial Stewardship Program: from April 2015 to September 2016.
(2) After launching Multidisciplinary Rounds in ICU: from October 2016 to May 2018.
(3) After launching "Time out": from June 2018 to March 2020.

Management information
Registered date
2019 Year 11 Month 19 Day
Last modified on
2019 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043394

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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