UMIN-CTR Clinical Trial

Public title

Community-Acquired & Nosocomial Pathogen United Surveillance for Methicillin-Resistant Staphylococcus aureus

Acronym

CANPUS-MRSA

Scientific Title

Community-Acquired & Nosocomial Pathogen United Surveillance for Methicillin-Resistant Staphylococcus aureus

Scientific Title:Acronym

CANPUS-MRSA

Region

Japan

Condition

staphylococcal infection cases

Classification by specialty

Pneumology	Infectious disease	Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The current surveillance consortium consists of two groups: a group composed of physicians of infection control/infectious disease departments (infection control/infectious disease group) mainly responsible for collecting HA-MRSA isolates, and a group composed of dermatologists (dermatology group) mainly responsible for collecting CA-MRSA isolates. The surveillance aims to clarify issues listed blow about MRSA clinical isolates from each group.

1) Infection control/infectious disease group
The ratio of HA-MRSA to CA-MRSA in all MRSA isolates
The proportion of CA-MRSA clones among strains that are not recognized as CA-MRSA
(Involvement of CA-MRSA clones in hospital-acquired infection)

2) Dermatology group
The proportion of MRSA isolates among all staphylococcal isolates from skin specimens
Difference in the proportion of MRSA between in-patients and out-patients
The proportion of CA-MRSA clones of all MRSA isolates

3) Both groups
Ratio of HA-MRSA to CA-MRSA
Isolation sites of HA-MRSA and CA-MRSA
Drug susceptibility of HA-MRSA and CA-MRSA
Genotyping of HA-MRSA and CA-MRSA
Patient demographics of patients with HA-MRSA and those with CA-MRSA
Clinical manifestations,
treatment outlines, outcome, and clonarity of CA-MRSA infection

Basic objectives2

Others

Basic objectives -Others

Regarding landscape of MRSA infection in Japan, many points are remained to be elucidated

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

1) Infection control/infectious disease group
The ratio of HA-MRSA to CA-MRSA in all MRSA isolates
The proportion of CA-MRSA clones among strains that are not recognized as CA-MRSA
(Involvement of CA-MRSA clones in hospital-acquired infection)

2) Dermatology group
The proportion of MRSA isolates among all staphylococcal isolates from skin specimens
Difference in the proportion of MRSA between in-patients and out-patients
The proportion of CA-MRSA clones of all MRSA isolates

3) Both groups
Ratio of HA-MRSA to CA-MRSA
Isolation sites of HA-MRSA and CA-MRSA
Drug susceptibility of HA-MRSA and CA-MRSA
Genotyping of HA-MRSA and CA-MRSA
Patient demographics of patients with HA-MRSA and those with CA-MRSA
Clinical manifestations,
treatment outlines, outcome, and clonarity of CA-MRSA infection

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(Infection control/infectious disease group)
Among isolates from staphylococcal infection cases which occur during the observation period,those meeting (1) and (2),or (1) and (3) of the criteria (1) to (3) listed below will be collected.
Two or more isolates from a single patient will be regarded as the same strain and should be counted as single isolate.

1) An isolate comfirmed to be MRSA.
According to the standard methods of the National Committee for Crinical Laboratory
Standards(NCCLS),incubate an isolate with 2% NaCl at 35 degrees centigrade for 24 hours;when the minimum inhibitory concentration of oxacillin against the isolate is 4ug/ml or more,the isolate will be regarded as MRSA.
Alternatively,an isolate can be tested with the NCCLS disk diffusion method;
even if the test shows oxacillin inhibition zone diameters of 10mm or less in the same incubation conditions as above,the isolated may be identified as MRSA.

2) An isolate from sterile sites,such as blood,ascites,pleural fluid,spinalfluid,
and joint aspirates.

3) A case where MRSA is likely to be a causative organism and unlikely to be a colonizing organism.
An isolate that can be identified as a causative organism if it is isolated from non-sterile sites(e.g.,sputum,pus,urine,stools). It is recommended to collect isolates from cases in which an ICD considered anti-MRSA chemotherapy is required.

(Dermatology group)
Staphylococcus aureus(including MRSA and methicillin-susceptible Staphylococcus aureus (MSSA)) will be included in the survey originated from specimens submitted to culture tests for potential skin infection from the out-patient dematology department or ward of each participating institution during the observation period.(This surveillance is mainly intended to collect MRSA isolates, but MSSA isolates will also be collected as control strains)
(The dermatology group will use the same definition of MRSA as that for the infection control/infectious disease group)

Key exclusion criteria

none

Target sample size

1200

Name of lead principal investigator

1st name
Middle name
Last name	Shigeru Kohno

Organization

Nagasaki University Graduate School
of Biomedical Sciences

Division name

Department of Molecular Microbiology and Immunology

Zip code

Address

1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.

TEL

Email

Name of contact person

1st name
Middle name
Last name	Katsuniri Yanagihara

Organization

Nagasaki University Hospital

Division name

Department of Laboratory Medicine

Zip code

Address

1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.

TEL

095-819-7418

Homepage URL

Email

k-yanagi@nagasaki-u.ac.jp

Institute

Nagasaki evaluation organization for clinical interventions

Institute

Department

Personal name

Organization

Nagasaki evaluation organization for clinical interventions

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院、富良野病院（北海道）、東北大学（宮城県）、埼玉医科大学（埼玉県）、
関東中央病院、同愛記念病院、帝京大学、東京医科大学、東邦大学医療センター大森病院（東京）愛知医科大学（愛知県）、大阪大学（大阪府）、兵庫医科大学（兵庫県）、岡山大学（岡山県）、高松赤十字病院（香川県）、長崎大学（長崎県）、大分大学（大分県）、琉球大学（沖縄県）

Date of disclosure of the study information

2010

Year

03

Month

26

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2008

Year

04

Month

13

Day

Date of IRB

Anticipated trial start date

2008

Year

05

Month

01

Day

Last follow-up date

2010

Year

03

Month

01

Day

Date of closure to data entry

2010

Year

03

Month

01

Day

Date trial data considered complete

2010

Year

03

Month

01

Day

Date analysis concluded

2010

Year

03

Month

01

Day

Other related information

prospective study

Registered date

2010

Year

03

Month

26

Day

Last modified on

2011

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003983