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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010124
Receipt No. R000011552
Scientific Title The analysis of MRSA strains isolated from nasal swabs and feces of neonates and children
Date of disclosure of the study information 2013/02/26
Last modified on 2019/09/11

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Basic information
Public title The analysis of MRSA strains isolated from nasal swabs and feces of neonates and children
Acronym The analysis of MRSA isolated from neonates and children
Scientific Title The analysis of MRSA strains isolated from nasal swabs and feces of neonates and children
Scientific Title:Acronym The analysis of MRSA isolated from neonates and children
Region
Japan

Condition
Condition Colonization of MRSA
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Infecton control of MRSA colonization at the NICU.
Basic objectives2 Others
Basic objectives -Others infection control
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The analysis of MRSA characteristics from feces and nasal swabs at the NICU.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Nasal swabs sampling
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
15 years-old >=
Gender Male and Female
Key inclusion criteria The subjects were selected from the neonates and children admitted those who were positive by MRSA screening test of nasal swab.
Key exclusion criteria the cases of nonconcurrence for our study by the person in parental authority
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Hisata
Organization Juntendo University Faculty of Medicine
Division name Pediatrics
Zip code 1138421
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email ken-hisa@juntendo.ac.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Nakao
Organization Juntendo University Faculty of Medicine
Division name Pediatrics
Zip code 1138421
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email aknakao@juntendo.ac.jp

Sponsor
Institute Department of Pediatrics, Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Pediatrics, Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Juntendo Hospital, institutional review board
Address 3-1-3 hongo, bunkyo-ku, Tokyo
Tel 0358021584
Email chiken@juntendo.ac.jp

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 順天堂医院(東京都) Juntendo University Hospital(Tokyo)、順天堂静岡病院(静岡県) Juntendo University Shizuoka Hospital(Shizuoka)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 26 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/24808943
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/24808943
Number of participants that the trial has enrolled 21
Results The feces of all nasal carriers contained MRSA at levels ranging from 4.0x102 to 2.8x108 colony forming units/g feces. The MRSA clones isolated from the feces and the nasal swabs of each patient were the same. Four MRSA clones, clonal complex (CC) 8-SCCmec IVl, CC8-SCCmec IVb, CC1-SCCmec IVa and CC5-SCCmec IIa were identified from 21 patients. All CC8-SCCmec IVl strains and one of three CC5-SCCmec IIa strains carried the toxic shock syndrome toxin gene.
Results date posted
2019 Year 09 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics MRSA strains were isolated from both the feces and nasal swabs of 21 nasal-MRSA carriers ranging from 10 to 104 days of age treated at the neonatal intensive care units of two hospitals. The molecular epidemiological characteristics of the isolates were determined: multilocus sequence types, spa-types, staphylococcal cassette chromosome mec (SCCmec) types, carriage of four exotoxin genes, and genes contained in commercially available kit.
Participant flow MRSA strains were isolated from both the feces and nasal swabs from nasal-MRSA carriers. The molecular epidemiological characteristics of the isolates were determined: multilocus sequence types, spa-types, staphylococcal cassette chromosome mec (SCCmec) types, carriage of four exotoxin genes, and genes contained in commercially available kit.
Adverse events none
Outcome measures The feces of all nasal carriers contained MRSA at levels ranging from 4.0 102 to 2.8 108 colony forming units per g feces. The MRSA clones isolated from the feces and the nasal swabs of each patient were the same. Four MRSA clones, clonal complex CC 8-SCCmec IVl, CC8-SCCmec IVb, CC1-SCCmec IVa and CC5-SCCmec IIa were identified from 21 patients. All CC8-SCCmec IVl strains and one of three CC5-SCCmec IIa strains carried the toxic shock syndrome toxin gene.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 22 Day
Date of IRB
2013 Year 02 Month 22 Day
Anticipated trial start date
2013 Year 02 Month 26 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 26 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011552

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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