UMIN-CTR Clinical Trial

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	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 15 Day
Date of IRB	2020 Year 01 Month 30 Day
Anticipated trial start date	2020 Year 01 Month 30 Day
Last follow-up date	2022 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 2021.

Management information
Registered date	2019 Year 11 Month 19 Day
Last modified on	2020 Year 05 Month 30 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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