UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011935 |
|---|---|
| Receipt number | 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 15:10:05 |
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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
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
y-morina@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013935
