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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034639
Receipt No. R000039490
Scientific Title Relationship between survey and prognosis concerning proper use of antibiotics against infection in ICU
Date of disclosure of the study information 2020/03/31
Last modified on 2020/04/26

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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/ctr_e/ctr_view.cgi?recptno=R000039490

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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