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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041359
Receipt No. R000047220
Scientific Title Study on pathogen identification by comprehensive genomic DNA analysis
Date of disclosure of the study information 2020/08/08
Last modified on 2021/08/12

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Basic information
Public title Study on identification of pathogens by bacterial DNA detection
Acronym Study on bacteria detection method
Scientific Title Study on pathogen identification by comprehensive genomic DNA analysis
Scientific Title:Acronym Tm mapping analysis
Region
Japan

Condition
Condition infectious disease
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to examine the usefulness of the Melting Temperature mapping (Tm mapping) analysis, which is a pathogen identification method, in patients with infectious diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Concordance rate with Tm mapping analysis and blood culture test in patients with infectious disease.
Key secondary outcomes 1: Relationship between Tm mapping analysis and blood test values. 2: Time until pathogen identification. 3: Relationship between clinical course and remaining time of bacterial DNA

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are diagnosed with bacterial infection or suspected of bacterial infection in the National Center for Child Health and Development.
Key exclusion criteria 1.Patients whose disease is significantly exacerbated by this study.
2. Other patients who the doctor judges as inappropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshinao
Middle name
Last name Kawai
Organization National Center for Child Health and Development
Division name Division of Immunology
Zip code 157-8535
Address 2-10-1 Okura,Setagaya-ku,tokyo,Japan
TEL +81334160181
Email kawai-t@ncchd.go.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ishikawa
Organization National Center for Child Health and Development
Division name Division of Immunology
Zip code 157-8535
Address 2-10-1 Okura,Setagaya-ku,tokyo,Japan
TEL +81334160181
Homepage URL
Email ishikawa-ta@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization National Center for Child Health and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Child Health and Development
Address 2-10-1 Okura,Setagaya-ku,tokyo,Japan
Tel +81334160181
Email rinri@ncchd.go.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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 08 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 110
Results Tm mapping positive n=30
Tm mapping negative n=80
Blood culture positive n=21
Blood culture negative n=89

Positive match rate 50%
Negative match rate 95%
Results date posted
2021 Year 02 Month 08 Day
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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2017 Year 11 Month 14 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Parameters
Patient sample (2 ml of blood, 1 ml of cerebrospinal fluid), medical records (age, medical record number, medical history, complications, medical examination contents of infectious disease, bacterial test, image diagnosis, body temperature, blood pressure, heart rate, respiratory rate, white blood cell count, CRP, procalcitonin, etc.)

Management information
Registered date
2020 Year 08 Month 08 Day
Last modified on
2021 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047220

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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