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

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 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

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

Value
https://center6.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