UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Survey of Antimicrobial Use in ICU Patients (J-SCRIPT)
Title of the study (Brief title)	Japanese Survey of AntimiCRobial Use in ICU PatienTs (J-SCRIPT)
Region	Japan

Condition
Condition	All patients who are treated in the ICU
Classification by specialty	Infectious disease Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1: To provide gross figures on antibiotic use (e.g. amount of prescribed antibiotics and purpose of prescription by agents) in Japanese ICUs 2: To clarify backgrounds which may influence better antibiotic prescription (e.g. implementation of antibiotic stewardship, involvement of infectious disease physicians) in Japanese ICUs 3: To provide antibiograms of several important bacteria (e.g. Pseudomonas aeruginosa, Staphylococcus aureus) in Japanese ICUs 4: To suggest appropriate and feasible measures to further facilitate judicious antibiotic use in Japanese ICUs
Basic objectives2	Others
Basic objectives -Others	Epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Amount of prescribed antibiotics in Daily Defined Dose/1000 patients 2. Susceptibility rates (%) of several important bacteria to major antibiotics
Key secondary outcomes

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	All patients who are treated in the ICU
Key exclusion criteria	Patients who expressed their will not participate in
Target sample size	500

Research contact person
Name of lead principal investigator	Yoshiro HAYASHI
Organization	Kameda general hospital
Division name	Department of critical care
Address	929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan 296-8602
TEL	04-7092-2211
Email	yoshi.icu@gmail.com

Public contact
Name of contact person	Masamitsu Sanui
Organization	Japanese Society of Education for Physicians and Trainees in Intensive Car
Division name	Clinical trial group
Address	3-11-3 Hongou NCK Building 5th Floor, Bunkyoku, Tokyo
TEL	03-5840-6131
Homepage URL	http://www.jseptic.com/rinsho/rinsho.html
Email	jsmc.icu.ctg@gmail.com

Sponsor
Institute	Japanese Society of Education for Physicians and Trainees in Intensive Care Clinical trial group
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)

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	2011 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 25 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.jseptic.com/rinsho/rinsho.html
Publication of results	Published
URL releasing results
Results
Other related information	Prospective cohort

Management information
Registered date	2011 Year 02 Month 22 Day
Last modified on	2018 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005798