UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between survey and prognosis concerning proper use of antibiotics against infection in ICU
Acronym	On the proper use of antibiotics at our hospital
Scientific Title	Relationship between survey and prognosis concerning proper use of antibiotics against infection in ICU
Scientific Title:Acronym	On the proper use of antibiotics at our hospital
Region	Japan

Condition
Condition	infection
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years, antibiotic - resistant drug - resistant bacteria are increasing, which is also a problem in our hospital. Development of new antimicrobial drugs has not progressed, and treatment of infections by drug-resistant bacteria is extremely difficult. In light of these circumstances, the proper use of antibiotics and the prevention and control of infection have become increasingly important. We would like to monitor drug resistance and antibiotic usage continuously by surveying and monitoring trends in infectious diseases at our hospital and accurately grasp changes in drug resistance and signs of expansion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proper use of antibiotics, relation between culture results and selection of antibiotics, artificial respiration period, organ perception Dyeing place
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	15 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who enter the ICU and are diagnosed with infection
Key exclusion criteria	When the research subject is refused to participate
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Mao Middle name Last name Kinoshita
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Anesthesiology
Zip code	6028566
Address	Kajiicho 465 Kamigyo-Ku Kyoto
TEL	0752515633
Email	mao6515@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Mao Middle name Last name Kinoshita
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Anesthesiology
Zip code	6028566
Address	Kajiicho 465 Kamigyo-Ku Kyoto
TEL	0752515633
Homepage URL
Email	mao6515@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
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	Kyoto Prefectural University of Medicine
Address	Kajiicho 465 Kamigyo-Ku Kyoto
Tel	0752515337
Email	rinri@koto.kpu-m.ac.jp

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	2020 Year 03 Month 31 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	Completed
Date of protocol fixation	2019 Year 12 Month 01 Day
Date of IRB	2019 Year 01 Month 08 Day
Anticipated trial start date	2019 Year 01 Month 09 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	None

Management information
Registered date	2018 Year 10 Month 25 Day
Last modified on	2020 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039490