UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023232
Receipt number 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 17:26:35

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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 or person

Institute

Department of General Internal Medicine, Kyushu University Hospital

Institute

Department

Personal name



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

Value
https://center6.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