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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003384
Receipt No. R000003983
Scientific Title Community-Acquired & Nosocomial Pathogen United Surveillance for Methicillin-Resistant Staphylococcus aureus
Date of disclosure of the study information 2010/03/26
Last modified on 2011/03/30

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Basic information
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
Condition staphylococcal infection cases
Classification by specialty
Pneumology Infectious disease Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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

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

Research contact person
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

Public contact
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

Sponsor
Institute Nagasaki evaluation organization for clinical interventions
Institute
Department

Funding Source
Organization Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
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
Other related information prospective study

Management information
Registered date
2010 Year 03 Month 26 Day
Last modified on
2011 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003983

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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