UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005122
Receipt number R000005798
Scientific Title Japanese Survey of Antimicrobial Use in ICU Patients (J-SCRIPT)
Date of disclosure of the study information 2011/02/25
Last modified on 2018/02/26 21:54:47

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Basic information

Public title

Japanese Survey of Antimicrobial Use in ICU Patients (J-SCRIPT)

Acronym

Japanese Survey of AntimiCRobial Use in ICU PatienTs (J-SCRIPT)

Scientific Title

Japanese Survey of Antimicrobial Use in ICU Patients (J-SCRIPT)

Scientific Title:Acronym

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

1st name
Middle name
Last name Yoshiro HAYASHI

Organization

Kameda general hospital

Division name

Department of critical care

Zip code


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

1st name
Middle name
Last name Masamitsu Sanui

Organization

Japanese Society of Education for Physicians and Trainees in Intensive Car

Division name

Clinical trial group

Zip code


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 or person

Institute

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

Institute

Department

Personal name



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


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

2011 Year 02 Month 25 Day


Related information

URL releasing protocol

http://www.jseptic.com/rinsho/rinsho.html

Publication of results

Published


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

Completed

Date of protocol fixation

2010 Year 12 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name