UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010124 |
|---|---|
| Receipt number | 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 12:46:58 |
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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
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
aknakao@juntendo.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Juntendo University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011552
