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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011935
Receipt No. R000013935
Scientific Title Prevalence study of MRSA colonization and infection for patients at NICU ward
Date of disclosure of the study information 2013/10/02
Last modified on 2015/12/07

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Basic information
Public title Prevalence study of MRSA colonization and infection for patients at NICU ward
Acronym MRSA prevalence study at NICU
Scientific Title Prevalence study of MRSA colonization and infection for patients at NICU ward
Scientific Title:Acronym MRSA prevalence study at NICU
Region
Japan

Condition
Condition MRSA infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the prevalence rate of MRSA colonization and infection for patients at NICU ward.
Basic objectives2 Others
Basic objectives -Others Evaluation of the clinical utility of MRSA screening at the hospitalization and hospital stay after hospitalization at NICU ward.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Number and rate of MRSA import into NICU ward.
2. Number and rate of MRSA acquisition at NICU ward.
Key secondary outcomes 1. Concordance bwtween PCR and culture method for MRSA testing.
2. Clinical utility of MRSA PCR testing for the diagnosis of MRSA infection.

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 months-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients at NICU ward.
Key exclusion criteria NA.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori Yanagihara
Organization Nagasaki University
Division name Department of Labolratory Medicine, Nagasaki University Graduate School of Biomedical Science
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 81-95-819-7574
Email k-yanagi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitomo Morinaga
Organization Nagasaki University
Division name Department of Labolratory Medicine, Nagasaki University Graduate School of Biomedical Science
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
TEL 81-95-819-7574
Homepage URL
Email y-morina@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nippon Becton Dickinson Company , Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 02 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
2013 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2013 Year 10 Month 01 Day
Last modified on
2015 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013935

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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