UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046622 |
|---|---|
| Receipt number | 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 | 2023/08/04 18:47:44 |
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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
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
trcshige@hiroshima-u.ac.jp
Sponsor or person
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
Personal name
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
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
| 2023 | Year | 09 | Month | 30 | 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
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
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 |
