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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046622
Receipt No. R000052962
Scientific Title Three Academic Societies Joint Antimicrobial susceptibility surveillance Program - Surgical Site Infection -
Date of disclosure of the study information 2022/01/14
Last modified on 2022/01/12

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Basic information
Public title Three Academic Societies Joint Antimicrobial susceptibility surveillance Program - Surgical Site Infection -
Acronym Three Academic Societies Joint Antimicrobial susceptibility surveillance Program - Surgical Site Infection -
Scientific Title Three Academic Societies Joint Antimicrobial susceptibility surveillance Program - Surgical Site Infection -
Scientific Title:Acronym Three Academic Societies Joint Antimicrobial susceptibility surveillance Program - Surgical Site Infection -
Region
Japan

Condition
Condition Surgical Site Infection
Classification by specialty
Infectious disease Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To review the antimicrobial susceptibility isolated from the patients with surgical site infection.
Basic objectives2 Others
Basic objectives -Others Nation wide surveillance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes antimicrobial susceptibility of isolated pathogen
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The person meet the conditions of the following 1) and 2), and the person meet the conditions of either 3) or 4).
1)Patients with 20year/old or more
2) Person who developed surgical site infections associated with digestive surgery.
3) A person, who can reject this study (opt out compatible), did not reject this study.
4) A person who has obtained a comprehensive consent regarding research use such as medical treatment information acquired in daily practice from research target person.
Key exclusion criteria The person meet the conditions of the following either 1) or 2)
1) The person who don't agree to this study.
2) The other person who are judges as unsuitable for this study by the principal investigator or investigators.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Ohge
Organization Hiroshima University Hospital
Division name Department of Infectious Disease
Zip code 734-8551
Address 1-2-3, Kasumi, Minami-ku, Hiroshima City, Hiroshima prefecture, Japan
TEL 0822571613
Email ohge@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Norifumi
Middle name
Last name Shigemoto
Organization Hiroshima University Hospital
Division name Department of Infectious Disease
Zip code 734-8551
Address 1-2-3, Kasumi, Minami-ku, Hiroshima City, Hiroshima prefecture, Japan
TEL 0822571613
Homepage URL
Email trcshige@hiroshima-u.ac.jp

Sponsor
Institute Three Academic Societies Joint Antimicrobial Surveillance Program (Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology)
Institute
Department

Funding Source
Organization Three Academic Societies Joint Antimicrobial Surveillance Program (Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Clinical Microbiology)
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 Ethical Committee for Epidemiology of Hiroshima University
Address 1-2-3, Kasumi, Minami-ku, Hiroshima City, Hiroshima prefecture, Japan
Tel 0822575907
Email iryo-seisaku@hiroshima-u.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
2022 Year 01 Month 14 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 Open public recruiting
Date of protocol fixation
2021 Year 11 Month 02 Day
Date of IRB
2021 Year 12 Month 13 Day
Anticipated trial start date
2021 Year 12 Month 14 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information surveillance

Management information
Registered date
2022 Year 01 Month 13 Day
Last modified on
2022 Year 01 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052962

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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