UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041359 |
|---|---|
| Receipt number | 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 | 2023/06/21 19:03:18 |
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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 method
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
1. Patients are diagnosed with bacterial infection or suspected of bacterial infection in the National Center for Child Health and Development.
2. written informed consent obtained at the appropriate time to conduct the TM experiment
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
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
ishikawa-ta@ncchd.go.jp
Sponsor or person
Institute
Division of Immunology, National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
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
Registered
Publication of results
Unpublished
Result
URL related to results and publications
Registered
Number of participants that the trial has enrolled
113
Results
Showing data under 16. The median age of 81 patients (93 samples) was 3.6 years. Of 23 samples identified by TM, 11 samples matched the bacterial species with BC (positive-match rate, 48%). Of 64 TM-negative samples, 62 samples were negative for BC (negative-match rate, 97%). Six samples, including one containing two pathogenic bacterial species, were not suitable for TM identification. In total, the matched samples were 73 of 93 samples (match rate, 78%).
Results date posted
| 2021 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ninety-two patients were enrolled.
Age, median (IQR) 4.1y (1.8-12.3)
Male, 78 (69%)
Background or underlying diseases, n (%)
Primary immunodeficiency 28 (16%)
Hematopoietic cell or organ transplantation 26 (24%)
Autoimmune disease 13 (10%)
None 46 (15%)
[Children under 16 years old]
Eighty-one patients were enrolled.
Age, median (IQR) 3.6y (1.0-7.4)
Male, 57 (70%)
Background or underlying diseases, n (%)
Primary immunodeficiency 16 (20%)
Hematopoietic cell or organ transplantation 19 (23%)
Autoimmune disease 8 (10%)
None 37 (47%)
Participant flow
Inclusion criteria included suspected or diagnosed BSI, and obtaining written informed consent at the appropriate time to conduct the Tm mapping experiment. Exclusion criteria included any underlying disease or complication that could be significantly exacerbated by this study.
Adverse events
None
Outcome measures
The median inspection time to identification of Tm mapping methods in the 17 samples measured after the procedures were established was 4.7 hours (IQR, 4.6-5.1). On the other hand, the time to positivity of blood cultures was 12.1 hours (IQR, 9.4-16.9) in aerobic cultures and 16.1 hours (IQR, 11.0-22.7) in anaerobic cultures
Plan to share IPD
We don't share IPD for observational studies.
IPD sharing Plan description
If you would like more information on IPD, please contact the corresponding author after the article has been published.
Progress
Recruitment status
Completed
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
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
The registration and observation period has ended.
Management information
Registered date
| 2020 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047220
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