UMIN-CTR Clinical Trial

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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