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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023232
Receipt No. R000026771
Scientific Title The comparison of the characteristics of Japanese SCCmec type II and type IV MRSA.
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/19

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Basic information
Public title The comparison of the characteristics of Japanese SCCmec type II and type IV MRSA.
Acronym The characteristics of Japanese SCCmec type II and type IV MRSA
Scientific Title The comparison of the characteristics of Japanese SCCmec type II and type IV MRSA.
Scientific Title:Acronym The characteristics of Japanese SCCmec type II and type IV MRSA
Region
Japan

Condition
Condition MRSA infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the clinical features and pathogenic genes (superantigens) between SCCmec type II and type IV MRSA in Japan and reveal the characteristic of SCCmec type II and IV MRSA.
Basic objectives2 Others
Basic objectives -Others the comparsion between Japanese SCCmec type II and type IV MRSA
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the clinical differences between SCCmec type II and type IV MRSA infection
Key secondary outcomes 1.patients' characteristics(age, sex, comorbidity, community-associated/health care-associated)
2.antimicrobial susceptibility
3.distribution of patogenic genes (sea,seb,sem,seo,tst)

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
0 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients from whom SCCmec type II or type IV MRSA was isolated between December 2014 and October 2015(only from skin and soft tissue or lower respiratpry tract specimens)
Key exclusion criteria patients who were treated at the neonatal intensive care unit or growing care unit
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyusyu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fujiko Mitsumoto-Kaseida
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5909
Homepage URL
Email mitsu-f@gim.med.kyushu-u.ac.jp

Sponsor
Institute Department of General Internal Medicine, Kyushu University Hospital
Institute
Department

Funding Source
Organization Department of General Internal Medicine, Kyushu University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 27-134
Org. issuing International ID_1 Kyushu University ethics committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 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
2015 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Japanese SCCmec type IV MRSA strains have been spread widely. Pathogenic gene combination patterns was dignificantly different between SCCmec type II and type IV MRSA.

Management information
Registered date
2016 Year 07 Month 19 Day
Last modified on
2016 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026771

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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