UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The comparison of the characteristics of Japanese SCCmec type II and type IV MRSA.
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Norihiro Furusyo
Organization	Kyusyu University Hospital
Division name	Department of General Internal Medicine
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	Fujiko Mitsumoto-Kaseida
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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