UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034639 |
|---|---|
| Receipt number | 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 09:17:30 |
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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
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
mao6515@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039490
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